The Freestyle Valve in Severe Necrotizing Aortic Root Endocarditis: Comorbidity Upon Outcome.

BACKGROUND: Treatment of severe necrotizing aortic root endocarditis (SNARE) carries a substantial perioperative risk. As an alternative to homografts, we assessed short-term outcome and future prognosis in patients undergoing root replacement using the Freestyle valve. METHODS: Between 2000 and 2018, a total of 45 patients (mean age 70.9 ± 8.3 years, 66% men) underwent aortic root replacement for SNARE using the Freestyle valve. Mean Society of Thoracic Surgeons mortality score and EuroScore II were 22.6% ± 17.1 and 29.3% ± 20.9, respectively. Prosthetic endocarditis was present in 70.1%, and aortic annulus patch repair was performed in 64% of the patients. Median follow-up was 3.6 years (range: 0.1-14.5) and was 100% complete. RESULTS: The 30-day mortality was 15.5%. During follow-up, there were no reoperations, while reinfection was suspected in one patient. Survival was significantly inferior to the general population with a standardized mortality ratio of 10.7 (95% confidence interval [CI]: 9.1-12.6) (p < 0.0001). In 30-day survivors and after correction for significant comorbidities in a Cox proportional hazards model, estimated survival probabilities at 1, 5, and 10 years were 98.7 (95% CI: 92.5-99.8%), 94.1 (77.9-98.5%), and 63.8 (28.4-85.2%). Estimated mean difference in survival probability was better for the general population after postoperative year 6, but within the 95% CI for no difference. CONCLUSION: Use of the Freestyle valve is reliable solution for the most complex cases with a low rate of reinfection. Early mortality is substantial and caused by the patient's condition and severity of the infection. Excess late mortality can be attributed to patient-specific comorbidities.

On-Pump versus Off-Pump Complete Arterial Revascularization Using Bilateral Internal Mammary Arteries and the T-Graft Technique: Clinical and Angiographic Results for 3,445 Patients in 13 Years of Follow-Up.

BACKGROUND: This is an investigation of complete arterial coronary artery bypass grafting (CACABG) using bilateral internal mammary arteries (IMA) and the T-graft technique either on- or off-pump as a routine approach to treat coronary artery disease. METHODS: Between January 2000 and December 2012, 3,445 patients underwent on-pump (n = 2,216) or off-pump (n = 1,229) CACABG. A 30-day follow-up was performed prospectively, a long-term follow-up by a questionnaire, and coronary angiography in selected patients. RESULTS: End points at 30 days were death, myocardial infarction, stroke, repeat revascularization, renal replacement, reoperation, sternal wound infection and atrial fibrillation. FitzGibbon A patency rates were 89.8 vs. 91.4% (p = 0.464) with consecutive percutaneous coronary intervention in the grafted area of 1.8 vs. 1.1% (p = 0.693) on- vs. off-pump, and no reoperation in the grafted area in both groups. CONCLUSION: CACABG by use of skeletonized bilateral IMA with the T-graft technique performed either on- or off-pump is a safe and effective approach.

Complete arterial revascularization using bilateral internal mammary artery in T-graft technique for multivessel coronary artery disease in on- or off-pump approach: does gender lose its historical impact on clinical outcome?

OBJECTIVES: Higher rates of mortality and morbidity have been reported in women undergoing coronary artery bypass grafting (CABG) compared with men. Different revascularization techniques (on-pump and off-pump) might influence this outcome. METHODS: We retrospectively analysed 3445 consecutively recruited patients (all comers) undergoing complete arterial CABG (CACABG) at a single centre between January 2000 and December 2012. CACABG was performed in all patients using bilateral skeletonized internal mammary artery in T-graft technique, either on-pump (n = 2216) or off-pump (n = 1229). Early results (30-day) and long-term follow-up data were analysed with respect to gender-specific outcome. RESULTS: Women were older than men in both groups (P < 0.001), and men had a higher body mass index (on-pump: P < 0.001; off-pump: P = 0.02) compared with women. Men displayed a higher extent of coronary artery disease (P < 0.001) and an overall lower ejection fraction (P < 0.001) when undergoing on-pump CABG. No gender differences were observed for late survival (P = 0.74 vs P = 0.52) in on-pump and off-pump procedures, respectively. Late follow-up revealed a higher rate of FitzGibbon A graft patency in men undergoing the on-pump approach (P = 0.006). CONCLUSIONS: CACABG using bilateral internal mammary artery in T-graft technique showed excellent early and long-term results. No significant gender-specific differences were observed in both groups undergoing CACABG with respect to 30 days mortality and morbidity as well as late survival. However, late follow-up revealed a higher graft patency in men undergoing the on-pump approach, compared to women.

Tricuspid regurgitation is a predictor of mortality after percutaneous mitral valve edge-to-edge repair.

AIMS: The aim of this study was to determine the impact of tricuspid regurgitation (TR) on mortality after edge-to-edge percutaneous mitral valve repair (PMVR), and also to analyse whether there is a difference in outcome between patients with improvement of TR after PMVR compared to patients without. METHODS AND RESULTS: Out of 197 consecutive patients who underwent PMVR, 139 patients with available follow-up (mean 428±386 days) were included in the study. Concomitant moderate/severe TR was present in 58.3% of patients. Kaplan-Meier analysis showed significantly reduced overall survival for patients with moderate/severe TR, compared to patients with none/mild TR (p=0.003). Cox multivariate regression analysis revealed severe TR at baseline as the strongest independent predictor of mortality (HR 4.367, p=0.003). An improvement of the baseline moderate/severe TR was observed in 45.5% of patients at 30-day follow-up. Patients with no improvement of TR after PMVR had a higher midterm mortality compared to patients in whom TR improved (40.5% versus 11.4%, p=0.005). CONCLUSIONS: More than half of patients undergoing PMVR have concomitant moderate/severe TR, which is associated with a worse outcome. Among predictors of mortality after edge-to-edge PMVR, severe TR at baseline is the most important. Patients with no improvement of TR at 30 days after PMVR have a significantly higher mortality at follow-up.

First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.

AIMS: Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure. METHODS AND RESULTS: Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status. CONCLUSIONS: For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.

First-in-human transcatheter tricuspid valve repair in a patient with severely regurgitant tricuspid valve.

BACKGROUND: Severe tricuspid regurgitation is associated with poor prognosis; however, there are limited Class I indications for intervention, and high-surgical risk patients may go untreated. We report the first-in-human successful transcatheter tricuspid valve repair for severe tricuspid regurgitation. OBJECTIVES: The objective of this study was to show the feasibility of a transcatheter tricuspid annular repair. METHODS: Compassionate-use approval for the procedure was obtained from the regulatory organization in Germany. To perform the transcatheter bicuspidization of the tricuspid valve, the Mitralign system was used to place pledgeted sutures by means of a trans-jugular venous approach. Insulated radiofrequency wires were positioned 2 to 5 mm from the base of the posterior leaflet, 2.6 cm apart. The sutures were drawn together and locked, plicating the posterior annulus. RESULTS: Reconstruction of the 3-dimensional transesophageal echocardiographic dataset at baseline revealed a tricuspid valve annular area of 14.1 cm(2), and effective regurgitant orifice area was 1.35 cm(2). There was a significant reduction in annular area (57%) and effective regurgitant orifice area (53%) measured with 3-dimensional transesophageal echocardiography, at 6.05 cm(2) and 0.63 cm(2), respectively. Hemodynamic parameters also improved with a reduction in right atrial pressure from 22 mm Hg at baseline, to 9 mm Hg and an increase in left ventricular stroke volume from 42 ml at baseline to 72 ml. CONCLUSIONS: Transcatheter tricuspid valve repair could become an effective treatment for high-surgical risk patients who are non-responsive to optimal medical therapy.

Increased Risk of Cerebral Embolization After Implantation of a Balloon-Expandable Aortic Valve Without Prior Balloon Valvuloplasty.

OBJECTIVES: The purpose of this study was to analyze the effect of transcatheter aortic valve replacement (TAVR) without versus with prior balloon aortic valvuloplasty (BAV) on the risk of cerebral embolization in patients who receive a balloon-expandable valve. BACKGROUND: Avoiding BAV prior to TAVR may simplify the procedure, but the risk of cerebral embolization is currently unknown. METHODS: A total of 87 consecutive high surgical-risk patients with no contraindications for diffusion-weighted magnetic resonance imaging (DW-MRI) were enrolled. Thirty-two patients received a balloon-expandable aortic valve with and 55 patients without BAV. The incidence, number, and volume of new ischemic lesions in DW-MRI performed 2 to 7 days after TAVI were evaluated. RESULTS: Mean age (83.8 ± 5.2 years vs. 82.9 ± 6.8 years) and sex (43.8% vs. 52.7% male) of the patients with versus without BAV, respectively, as well as other demographic and hemodynamic data were not significantly different between both groups. The procedural success rate was 93.5% with and 98.2% without BAV, and procedure duration and contrast volume were significantly lower without BAV. The incidence of new cerebral ischemic lesions in the total cohort was 66.7%. Compared with patients with BAV, those without BAV had a significantly higher total volume of cerebral ischemic lesions (235.4 ± 331.4 mm(3) vs. 89.5 ± 128.2 mm(3); p = 0.01). CONCLUSIONS: The implantation of a balloon-expandable aortic valve without versus with prior BAV, although performed with a shorter procedure time and lower contrast volume, is associated with a significantly higher volume of cerebral ischemic lesions.

Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.

OBJECTIVES: This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR). BACKGROUND: The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak. METHODS: The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria). RESULTS: Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II. CONCLUSIONS: This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.

Aortic valve replacement after transapical valve-in-valve implantation.

Transapical valve-in-valve aortic valve replacement has emerged as an attractive alternative for high-risk surgery in elderly patients with degenerated aortic bioprothesis. Despite recent encouraging results, further clinical investigation is required to avoid potential cases of prosthesis-aortic annulus mismatch. We report a surgical valve replacement in a high-risk patient with dysfunctional transapical, implanted aortic valve-in-valve prosthesis 1 year after implantation.

The Mosaic porcine bioprosthesis: role of age on clinical performance in aortic position.

BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and α-amino oleic acid antimineralization treatment to improve durability and hemodynamic function. This single-center study reports on the performance of the Mosaic bioprosthesis in patients 65 years of age or less and patients older than 65 years at implantation. METHODS: Between 1994 and 1999, 88 younger patients (mean age, 58 years) and 167 older patients (mean age, 72 years) were enrolled in this prospective nonrandomized clinical trial. Follow-up visits were performed after 30 days, 6 months, and annually. Cumulative follow-up was 751 patient-years in the younger group and 1223 patient-years in the older group. RESULTS: Mean systolic gradient increased significantly to 17.0 and 14.7 mm Hg in younger and older patients, respectively, at their latest follow-up (P < .001). Effective orifice area values decreased significantly to 1.8 and 1.6 cm(2) (P < .001). Overall, effective orifice area values were significantly higher in younger patients (P < .001). Transvalvular regurgitation increased over time (P < .001) but remained mild or less in more than 95% of the patients. Freedom from adverse events at latest follow-up in younger and older patients, respectively, were as follows: structural valve deterioration, 85.7% and 86.2% (P < .05); endocarditis, 87.5% and 98.5% (P < .01); valvular thrombosis, 98.8% and 97.1% (not significant); and explantation, 68.9% and 77.9% (P < .01). CONCLUSIONS: Hemodynamic performance is similar in both groups. In the younger patients the incidence of structural valve disease, endocarditis, valve-related reoperation, and explantation is higher. The incidence in structural valve deterioration in the younger patients tends to be similar or lower compared with that seen in the literature.

Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years.

BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and alpha-amino oleic acid (AOA) antimineralisation treatment to improve haemodynamic performance and durability. This single-centre study reports the clinical results, including haemodynamic performance, of the Mosaic bioprosthesis after implant in aortic or mitral position. METHODS: Between February 1994 and October 1999, 255 patients with aortic valve replacement (AVR; mean age: 67 years, range: 23-82 years) and 47 patients with mitral valve replacement (MVR; mean age: 67 years, range: 41-84 years) were enrolled in this prospective non-randomised clinical trial. Follow-up visits were performed 30 days and 6 months after implant and annually thereafter. The cumulative follow-up was 1976.2 patient-years (pt-yrs) after AVR (median: 8.3 years, maximum: 14.0 years) and 336.9 pt-yrs after mitral valve replacement (MVR) (median: 8.2 years, maximum: 13.3 years). RESULTS: After AVR, mean systolic gradient and effective orifice area at 4, 8 and 13 years follow-up were 13.3+/-5.6, 15.5+/-7.7 and 16.0+/-7.2 mmHg and 1.8+/-0.5, 1.8+/-0.5 and 1.7+/-0.4 cm(2). After MVR, respective data were 4.7+/-2.1, 4.3+/-1.2 and 5.0 mmHg (only one recording) and 2.2+/-0.7, 2.3+/-0.6 and 1.8 cm(2). Transvalvular regurgitation at 13-year follow-up was mild or less in both the AVR and MVR patients. Thirteen-year survival was 63.1+/-4.5% in the AVR group and 51.2+/-13.6% in the MVR group. Early mortality after AVR and MVR was 1.2% and 0.0%, respectively; late mortality was 3.2%pt-yr(-1) and 3.3%pt-yr(-1), including a valve-related/unexplained mortality of 1.1%pt-yr(-1) and 0.9%pt-yr(-1). Freedom from adverse events in the AVR and MVR group was permanent neurological event: 97.4+/-1.2% and 96.0+/-3.9%; valvular thrombosis: 97.8+/-1.1% and 100%; structural valve deterioration: 84.8+/-7.8% and 93.8+/-6.1%; explant: 73.3+/-7.3% and 89.3+/-6.5%. CONCLUSIONS: The Mosaic bioprosthesis demonstrates excellent clinical performance and safety after 13 years of follow-up. Continued follow-up will determine whether this new design will provide increased durability.

Factors influencing survival and postoperative quality of life after mitral valve reconstruction.

OBJECTIVE: Mitral valve reconstruction (MVR) is the preferred treatment for regurgitant lesions. Clinical benefit is well documented, but comparative data scrutinising factors influencing survival and postoperative quality of life (QOL) in different subsets of patients are missing. We hypothesised that mitral valve reconstruction for mitral regurgitation benefits the patients, regardless of the valve pathology. METHODS: In this study, 663 consecutive patients undergoing mitral valve reconstruction using Carpentier techniques were assigned to four different groups. Aetiology of mitral regurgitation was degenerative (DEG) in 372 (56.1%) patients and ischaemic (ISC) in 157 (23.6%). Cardiomyopathy (CMP) was present in 23 (3.4%) cases and combined degenerative regurgitation plus coronary artery disease (DEG+CAD) in 111 (16.7%) patients. Survival was evaluated using a Cox proportional hazards model. Postoperative QOL was assessed using the short form (SF)-36 questionnaire in a multivariate analysis of covariance. RESULTS: The overall 30-day mortality was 1.1% (0.3%, 1.9%, 0% and 2.7% for groups DEG, ISC, CMP and DEG+CAD, respectively). The median preoperative NYHA class and grade MI was 3 and evenly distributed between groups. After a mean follow-up of 4.1+/-3.4 years, MVR proved to be effective in all groups with 90.3% of patients in the NYHA classes I and II (p<0.001). At 5 years, unadjusted survival was 90.3%, 69.7%, 50.5% and 86.2%. However, after correcting for age, ejection fraction, chronic obstructive pulmonary disorder (COPD), renal insufficiency and the preoperative NYHA class, survival in groups ISC and DEG+CAD was comparable. Group allocation was not a predictor for late death. Postoperative QOL was inferior in female patients in all SF-36 scales (p<0.01) and was impaired by co-morbidities. QOL scores were best for patients in group DEG and worst in group CMP. In a multivariate model correcting for gender, age and co-morbidities (COPD, treated diabetes, renal insufficiency, subjective heart rhythm, preoperative NYHA class and previous myocardial infarction), postoperative QOL was comparable between groups. For the majority of patients with degenerative MR, postoperative life expectancy as well as QOL is similar to a normal population. CONCLUSIONS: MVR was safely and effectively accomplished in all groups. Survival and postoperative QOL was determined by left ventricular function and co-morbidities rather than MR aetiology.

Hemodynamic performance of the Medtronic Mosaic porcine bioprosthesis up to ten years.

BACKGROUND: The Mosaic bioprosthesis (Medtronic, Minneapolis, MN) is a third-generation stented porcine bioprosthesis combining physiologic fixation and amino oleic acid antimineralization treatment to improve hemodynamic performance and durability. The findings of this single-center experience with this valve were evaluated to determine the clinical and hemodynamic performance. METHODS: Between February 1994 and October 1999, we enrolled 255 patients with aortic valve replacement (AVR) with a mean age of 67 years (range, 23 to 82 years) and 47 patients with mitral valve replacement (MVR) with a mean age of 67 years (range, 41 to 84 years) in this post-United States Food and Drug Administration approval prospective and nonrandomized clinical trial. Patients were followed-up, including serial echocardiographic assessment, within 30 days, at 6 months, and annually thereafter. The cumulative follow-up was 1540 patient-years for AVR (mean, 6.1 years; maximum, 10 years) and 250 patient-years for MVR (mean, 5.4 years, maximum; 10 years). RESULTS: Early mortality after AVR (<30 days) was 0.8%; late mortality per patient-year was 3.5%, including a valve-related/unexplained mortality of 1.1%. Early mortality after MVR (<30 days) was 0.0%; late mortality per patient-year was 2.8%, including a valve-related/unexplained mortality of 1.2%. Median postoperative gradient and effective orifice area for all valves after AVR were (early, n = 252; 5 years, n = 161; 9 years, n = 43) 13.7, 12.3, and 11.7 mm Hg and 1.9, 1.8, and 1.8 cm2 at early, 5 years, and 9 years, respectively. With MVR respective data were (early, n = 46; 5 years, n = 25; 7 years, n = 13) 4.6, 4.1, and 3.9 mm Hg and 1.8, 2.2, and 2.3 cm2. At 10 years, freedom from adverse events in the AVR group and MVR group was, respectively, thromboembolism, 86.6% +/- 6.6% and 86.3% +/- 9.8%; permanent neurologic event, 91.2% +/- 6.8% and 90.9% +/- 8.7%; valve thrombosis, 98.2% +/- 0.8% and 100%; structural valve deterioration, 87.1% +/- 6.7% and 100%. CONCLUSIONS: Our midterm results demonstrate clinical safety and good performance of the Mosaic bioprosthesis. Continued follow-up will determine if this new design will provide increased durability.