Mitral re-valve-in-valve as a new perspective for high-risk patients with prosthetic valve dysfunction: case reports.

Background: Mitral valve diseases are a common medical condition, and surgery is the most used therapeutic approach. The need for less invasive interventions led to the development of transcatheter valve implantation in high-risk patients. However, the treatment to the dysfunctions of these prosthetic valves is still uncertain, and the yield and safety of repeated transcatheter valve implantations remain unclear. Cases summary: A 69-year-old Caucasian woman with three previous mitral valve procedures performed due to rheumatic valve disease (currently with a biological prosthetic mitral valve) and a 76-year-old Latin woman with previous liver transplantation (due to metabolic-associated fatty liver disease) and biological mitral prosthesis due to mitral valve prolapse with severe regurgitation underwent mitral valve-in-valve (ViV) transcatheter implantation at the time of dysfunction of their surgical prostheses. Later, these patients developed prosthetic valve dysfunction and clinical worsening, requiring another invasive procedure. Due to maintained high-risk status and unfavourable clinical conditions for surgery, re-valve-in-valve (re-ViV) was performed. Discussion: Valve-in-valve transcatheter mitral valve implantation was approved in 2017, and, since then, it has been used in several countries, mainly in high-risk patients. Nevertheless, these prosthetic valves may complicate with stenosis or regurgitation, demanding reinterventions. Although there are favourable data for mitral ViV, re-ViV still lacks robust data to support its performance, with only case reports in the literature so far. It is possible that in high-risk patients, there is a greater benefit from re-ViV when compared with the surgical strategy. However, this hypothesis must be studied in future controlled trials.

Delayed left main coronary obstruction following transfemoral inovare transcatheter aortic valve replacement: A challenging case.

Coronary obstruction is an uncommon and severe complication after a transcatheter aortic valve replacement (TAVR), that occurs during the procedure in the vast majority of patients. In the present case even in the absence of classic risk factors, an acute coronary syndrome occurred one day after TAVR. Selective angiography revealed a severe left main ostium obstruction by the bulky native leaflet calcification. This is the first case of delayed presentation of coronary obstruction with a transfemoral balloon-expandable valve using the Inovare bioprosthesis (Braile Biomedica, Brazil). In addition, after drug-eluting stent placement in the left main coronary, intravascular ultrasound revealed severe stent underexpansion, so that a second layer of a bare-metal stent and high-pressure balloon post-dilatation was necessary to improve the final result. The patient was discharged after 7 days, and at the 6-month follow-up remained asymptomatic. .

Transcatheter Valve-in-Valve Procedures for Bioprosthetic Valve Dysfunction in Patients With Rheumatic vs. Non-Rheumatic Valvular Heart Disease.

Background: Bioprosthetic heart valve has limited durability and lower long-term performance especially in rheumatic heart disease (RHD) patients that are often subject to multiple redo operations. Minimally invasive procedures, such as transcatheter valve-in-valve (ViV) implantation, may offer an attractive alternative, although data is lacking. The aim of this study was to evaluate the baseline characteristics and clinical outcomes in rheumatic vs. non-rheumatic patients undergoing ViV procedures for severe bioprosthetic valve dysfunction. Methods: Single center, prospective study, including consecutive patients undergoing transcatheter ViV implantation in aortic, mitral and tricuspid position, from May 2015 to September 2020. RHD was defined according to clinical history, previous echocardiographic and surgical findings. Results: Among 106 patients included, 69 had rheumatic etiology and 37 were non-rheumatic. Rheumatic patients had higher incidence of female sex (73.9 vs. 43.2%, respectively; p = 0.004), atrial fibrillation (82.6 vs. 45.9%, respectively; p < 0.001), and 2 or more prior surgeries (68.1 vs. 32.4%, respectively; p = 0.001). Although, device success was similar between groups (75.4 vs. 89.2% in rheumatic vs. non-rheumatic, respectively; p = 0.148), there was a trend toward higher 30-day mortality rates in the rheumatic patients (21.7 vs. 5.4%, respectively; p = 0.057). Still, at median follow-up of 20.7 [5.1-30.4] months, cumulative mortality was similar between both groups (p = 0.779). Conclusion: Transcatheter ViV implantation is an acceptable alternative to redo operations in the treatment of patients with RHD and severe bioprosthetic valve dysfunction. Despite similar device success rates, rheumatic patients present higher 30-day mortality rates with good mid-term clinical outcomes. Future studies with a larger number of patients and follow-up are still warranted, to firmly conclude on the role transcatheter ViV procedures in the RHD population.

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.

BACKGROUND: Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR. METHODS: Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ≥10 mm Hg and significant residual mitral regurgitation (MR) as ≥ moderate. RESULTS: A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (P<0.001). Mean gradient across the mitral valve postprocedure was 5.7±2.8 mm Hg (≥5 mm Hg; 61.4% of patients). Significant residual MS occurred in 8.2% of the ViV and 12.0% of the ViR patients (P=0.09). Significant residual MR was more common in ViR patients (16.6% versus 3.1%; P<0.001) and was associated with lower survival at 4 years (35.1% versus 61.6%; P=0.02). The rates of Mitral Valve Academic Research Consortium-defined device success were low for both procedures (39.4% total; 32.0% ViR versus 41.3% ViV; P=0.01), mostly related to having postprocedural mean gradient ≥5 mm Hg. Correlates for residual MS were smaller true internal diameter, younger age, and larger body mass index. The only correlate for residual MR was ViR. Significant residual MS (subhazard ratio, 4.67; 95% CI, 1.74-12.56; P=0.002) and significant residual MR (subhazard ratio, 7.88; 95% CI, 2.88-21.53; P<0.001) were both independently associated with repeat mitral valve replacement. CONCLUSIONS: Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.

Double transcatheter balloon-expandable valve implantation for severe valve dysfunction in high-risk patients: initial experience.

OBJECTIVES: Concomitant valvular heart valve disease is a frequent finding, with higher morbidity and mortality among patients undergoing redo surgical procedures. Our goal was to report our initial experience with combined transcatheter Inovare bioprosthesis implants for severe valve dysfunction. METHODS: Among 300 transcatheter procedures, a total of 6 patients had concurrent simultaneous transcatheter bioprosthesis implants for severe mitral bioprosthesis failure (valve-in-valve), with a second valve procedure that included native aortic (n = 2) or degenerated bioprostheses in the aortic position (n = 4). During the procedures, all patients were treated with a balloon-expandable Inovare transcatheter valve, using the transapical approach. RESULTS: Patients were highly symptomatic [New York Heart Association (NYHA) functional class IV: 100%], with a mean age of 62 ± 5 years, yielding a mean European System for Cardiac Operative Risk II (EuroSCORE II) of 24.0 ± 10.1%. There was a mean of 1.6 ± 0.4 prior valve operations/patient, with a median time from prior mitral bioprosthesis surgery of 13.0 (9.2-20.0) years. Device success was 100% according to the Mitral Valve Academic Research Consortium and the Valve Academic Research Consortium-2 criteria. During the hospital stay, only 1 patient required dialysis, and the median intensive care unit and hospital lengths of stay were 5.0 (3.2-6.7) days and 16.0 (12.2-21.2) days, respectively. No deaths occurred at 30 days; at a median follow-up of 287 (194-437) days, 1 patient died of a non-cardiac cause and the rest of patients were in NYHA functional class I or II, with normofunctioning bioprostheses. CONCLUSIONS: Transcatheter double valve interventions using the Inovare bioprosthesis in this initial series were shown to be a reasonable alternative to redo surgical operations. The short- and mid-term clinical and echocardiographic outcomes demonstrate promising results, although future studies with a larger number of patients and longer follow-up are warranted.

Transcatheter mitral valve-in-valve implantation: reports of the first 50 cases from a Latin American Centre.

OBJECTIVES: Our goal was to analyse the initial results of the first 50 transapical transcatheter mitral valve-in-valve procedures performed in a single Latin American centre. METHODS: A prospective, single centre, database analysis was conducted to evaluate immediate, 30-day and 1-year postoperative results of 50 consecutive patients who had a transcatheter mitral valve-in-valve procedure from May 2015 to June 2018. All patients were operated on in a hybrid operating room and received a balloon-expandable valve via the transapical approach. Preoperative and postoperative characteristics were analysed and compared between the first 25 and the second 25 patients to evaluate the impact of the learning curve. Twenty patients had a follow-up examination at 1 year. RESULTS: There was a 98% device success rate. The patients had a mean age of 64.8 years; 72% were women; 80% were in New York Heart Association functional class ≥III preoperatively; and 36% of the procedures were urgent. The mean Society of Thoracic Surgeons scores and EuroSCORE II were 8.3% and 12.4%, respectively. Patients had a median of 2 previous operations; valve durability was 12.1 years; and 64% mitral valve disease of rheumatic fever aetiology. Echocardiography showed decreases in the maximum and mean mitral gradients from 23.5 to 14.6 and 11.5 to 6.4 mmHg postoperatively; the overall mean hospitalization period was 15 days. The overall mortality rate at 30 days was 14%, with 1 intraprocedural death. Further subanalyses between the first and the second half of the cases showed a drop in the mortality rate from 20% to 8% (P < 0.01). CONCLUSION: The transcatheter mitral valve-in-valve procedure was shown to be a safe and effective procedure to treat bioprosthetic dysfunction, with potential benefits in patients with rheumatic disease.

Early outcomes of transcatheter tricuspid valve-in-valve implantation: a case series.

OBJECTIVES: In this study, we sought to evaluate early outcomes of transcatheter valve-in-valve implantation in patients with a degenerated bioprosthesis in the tricuspid position. METHODS: We used a prospective study, which included patients with a degenerated bioprosthesis in the tricuspid position who were considered high-risk by our heart team and who underwent a valve-in-valve implantation. The procedures were performed via transjugular venous access and were done with the patient under general anaesthesia with transoesophageal echocardiographic and fluoroscopic guidance. Perioperative data were analysed, and the patients were followed prospectively. RESULTS: Seven patients were included. The baseline diagnoses were 3 patients with Ebstein's anomaly, 1 patient with tetralogy of Fallot, 1 patient with neonatal endocarditis, 1 patient with ventricular septal defect with a double tricuspid lesion and 1 patient with rheumatic mitral and tricuspid valve who underwent a combined transapical mitral and transjugular tricuspid valve-in-valve implantation. The mean age was 33 ± 10.8 years and 57.1% of the patients were men. The mean number of previous thoracotomies was 3 ± 2 (range 1-5) procedures. The mean follow-up was 1.24 years. The implant was successful in all cases, and there was no need for conversion to open surgery. There were no deaths during the study period, and all patients are currently in the New York Heart Association functional class I/II. There was a statistically significant difference when the mean transvalvular gradients preimplantation and postimplantation were compared (P < 0.001). CONCLUSIONS: Percutaneous tricuspid valve implantation should be considered a safe and effective therapy and stands as a viable, reliable alternative for the treatment of a degenerated bioprosthesis in high-surgical-risk/inoperable patients.

Thrombocytopenia After Transcatheter Valve-in-Valve Implantation: Prognostic Marker or Mere Finding?

OBJECTIVE: To analyze the behavior of platelets after transcatheter valve-in-valve implantation for the treatment of degenerated bioprosthesis and how they correlate with adverse events upon follow-up. METHODS: Retrospective analysis of 28 patients who received a valve-in-valve implant, 5 in aortic, 18 in mitral and 5 in tricuspid positions. Data were compared with 74 patients submitted to conventional redo valvular replacements during the same period, and both groups' platelet curves were analyzed. Statistical analysis was conducted using the IBM SPSS Statistics(r) 20 for Windows. RESULTS: All patients in the valve-in-valve group developed thrombocytopenia, 25% presenting mild (<150.000/µL), 54% moderate (<100.000/µL) and 21% severe (<50.000/µL) thrombocytopenia. The platelet nadir was on the 4th postoperative day for aortic ViV, 2nd for mitral and 3rd for tricuspid patients, with the majority of patients recovering regular platelet count. However, the aortic subgroup comparison between valve-in-valve and conventional surgery showed a statistically significant difference from the 7th day onwards, where valve-in-valve patients had more severe and longer lasting thrombocytopenia. This, however, did not translate into a higher postoperative risk. In our study population, postoperative thrombocytopenia did not correlate with greater occurrence of adverse outcomes and only normal preoperative platelet count could significantly predict a postoperative drop >50%. CONCLUSION: Although thrombocytopenia is an extremely common finding after valve-in-valve procedures, the degree of platelet count drop did not correlate with greater incidence of postoperative adverse outcomes in our study population.

Thrombocytopenia after transcatheter valve-in-valve implantation: prognostic marker or mere finding?

Abstract Objective: To analyze the behavior of platelets after transcatheter valve-in-valve implantation for the treatment of degenerated bioprosthesis and how they correlate with adverse events upon follow-up. Methods: Retrospective analysis of 28 patients who received a valve-in-valve implant, 5 in aortic, 18 in mitral and 5 in tricuspid positions. Data were compared with 74 patients submitted to conventional redo valvular replacements during the same period, and both groups' platelet curves were analyzed. Statistical analysis was conducted using the IBM SPSS Statistics(r) 20 for Windows. Results: All patients in the valve-in-valve group developed thrombocytopenia, 25% presenting mild (<150.000/µL), 54% moderate (<100.000/µL) and 21% severe (<50.000/µL) thrombocytopenia. The platelet nadir was on the 4th postoperative day for aortic ViV, 2nd for mitral and 3rd for tricuspid patients, with the majority of patients recovering regular platelet count. However, the aortic subgroup comparison between valve-in-valve and conventional surgery showed a statistically significant difference from the 7th day onwards, where valve-in-valve patients had more severe and longer lasting thrombocytopenia. This, however, did not translate into a higher postoperative risk. In our study population, postoperative thrombocytopenia did not correlate with greater occurrence of adverse outcomes and only normal preoperative platelet count could significantly predict a postoperative drop >50%. Conclusion: Although thrombocytopenia is an extremely common finding after valve-in-valve procedures, the degree of platelet count drop did not correlate with greater incidence of postoperative adverse outcomes in our study population.

Incidence, predictors, and clinical outcomes of coronary obstruction following transcatheter aortic valve replacement for degenerative bioprosthetic surgical valves: insights from the VIVID registry.

Aims: There are limited data on coronary obstruction following transcatheter valve-in-valve (ViV) implantation inside failed aortic bioprostheses. The objectives of this study were to determine the incidence, predictors, and clinical outcomes of coronary obstruction in transcatheter ViV procedures. Methods and results: A total of 1612 aortic procedures from the Valve-in-Valve International Data (VIVID) Registry were evaluated. Data were subject to centralized blinded corelab computed tomography (CT) analysis in a subset of patients. The virtual transcatheter valve to coronary ostium distance (VTC) was determined. A total of 37 patients (2.3%) had clinically evident coronary obstruction. Baseline clinical characteristics in the coronary obstruction patients were similar to controls. Coronary obstruction was more common in stented bioprostheses with externally mounted leaflets or stentless bioprostheses than in stented with internally mounted leaflets bioprostheses (6.1% vs. 3.7% vs. 0.8%, respectively; P < 0.001). CT measurements were obtained in 20 (54%) and 90 (5.4%) of patients with and without coronary obstruction, respectively. VTC distance was shorter in coronary obstruction patients in relation to controls (3.24 ± 2.22 vs. 6.30 ± 2.34, respectively; P < 0.001). Using multivariable analysis, the use of a stentless or stented bioprosthesis with externally mounted leaflets [odds ratio (OR): 7.67; 95% confidence interval (CI): 3.14-18.7; P < 0.001] associated with coronary obstruction for the global population. In a second model with CT data, a shorter VTC distance predicted this complication (OR: 0.22 per 1 mm increase; 95% CI: 0.09-0.51; P < 0.001), with an optimal cut-off level of 4 mm (area under the curve: 0.943; P < 0.001). Coronary obstruction was associated with a high 30-day mortality (52.9% vs. 3.9% in the controls, respectively; P < 0.001). Conclusion: Coronary obstruction following aortic ViV procedures is a life-threatening complication that occurred more frequently in patients with prior stentless or stented bioprostheses with externally mounted leaflets and in those with a short VTC.

Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

Objectives: Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. Methods: The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. Results: A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. Conclusions: The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

When Aortic Stenting Alone Does Not Solve It: Mass Effect of Thoracic Aneurysms.

Thoracic aneurysms can potentially cause substantial compression of adjacent structures, creating substantial symptoms. We present a case of a 56-year-old woman with fatigue and dyspnea for 6 months. We discuss her initial endovascular treatment, which was insufficient to improve symptoms, and further surgical intervention was needed to solve the issue.

Transcatheter Replacement of Failed Bioprosthetic Valves: Large Multicenter Assessment of the Effect of Implantation Depth on Hemodynamics After Aortic Valve-in-Valve.

BACKGROUND: Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV. METHODS AND RESULTS: Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ≥20 mm Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002). CONCLUSIONS: High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.

New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up.

AIMS: Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. METHODS AND RESULTS: Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. CONCLUSIONS: Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.

Ventricular assist device implantation with CentriMag VAS® for biventricular mechanical support.

Despite recent advances in acute heart failure treatment, actual results remain limited in refractory cardiogenic shock. Temporary ventricular assist devices have emerged as an alternative in this serious and challenging medical. The purpose of this communication is to present a case of refractory cardiogenic shock, underwent temporary left ventricular assistance device implantation, progressing to right ventricular failure and conversion to biventricular support.

Off-pump transapical closure of a mitral periprosthetic leak: a new approach to a difficult problem.

A 60-year old male patient with multiple risk factors and two previous interventions over the mitral valve was admitted to the emergency unit with symptoms of cardiac failure. Initial examination revealed a competent mitral bioprosthesis with severe perivalvular mitral insufficiency. Based on previous experiences with transapical procedures, a transapical transcatheter closure of the perivalvular leak was performed. The apex was punctured with a 7 French introducer sheath, and a hydrophilic guidewire was advanced with the aid of a right Judkins catheter and positioned across the defect in the left atrium. Fluoroscopic and tridimensional transoesophageal echocardiography was used to guide the manoeuvre. Next, a long introducer sheath was advanced through the guidewire and positioned inside the left atrium. Two Amplatzer Vascular Plug II (St Jude Medical) were deployed, resulting in a significant reduction in the perivalvular leak. The procedure was considered to be successful. The patient regained consciousness, and the orotracheal tube was removed in the operating theatre. No neurological deficits were detected, and the patient was transferred to the intensive care unit. The patient recovered well and was transferred to the ward after 1 day. Discharge was accomplished after 4 days.