Valve-related Outcomes Research Articles

Ross procedure or mechanical aortic valve, which is the best lifetime option for an 18-year-old? A decision analysis

Objective(s)Identifying the optimal solution for young adults requiring aortic valve replacement (AVR) is challenging, given the variety of options and their lifetime complication risks, impacts on quality of life, and costs. Decision analytic techniques make comparisons incorporating these measures. We evaluated lifetime valve-related outcomes of mechanical aortic valve replacement (mAVR) versus the Ross procedure (Ross) using decision tree microsimulations modeling. MethodsTransition probabilities, utilities, and costs derived from published reports were entered into a Markov model decision tree to explore progression between health states for hypothetical 18-year-old patients. In total, 20,000 Monte Carlo microsimulations were performed to model mortality, quality-adjusted-life-years (QALYs), and health care costs. The incremental cost-effectiveness ratio (ICER) was calculated. Sensitivity analyses was performed to identify transition probabilities at which the preferred strategy switched from baseline. ResultsFrom modeling, average 20-year mortality was 16.3% and 23.2% for Ross and mAVR, respectively. Average 20-year freedom from stroke and major bleeding was 98.6% and 94.6% for Ross, and 90.0% and 82.2% for mAVR, respectively. Average individual lifetime (60 postoperative years) utility (28.3 vs 23.5 QALYs) and cost ($54,233 vs $507,240) favored Ross over mAVR. The average ICER demonstrated that each QALY would cost $95,345 more for mAVR. Sensitivity analysis revealed late annual probabilities of autograft/left ventricular outflow tract disease and homograft/right ventricular outflow tract disease after Ross, and late death after mAVR, to be important ICER determinants. ConclusionsOur modeling suggests that Ross is preferred to mAVR, with superior freedom from valve-related morbidity and mortality, and improved cost-utility for young adults requiring aortic valve surgery.

From fixed-pressure paediGAV to programmable proGAV/proSA serial valves for pediatric hydrocephalus within the 1st year of life: a technical single-center analysis.

Programmable valves have gained increasing popularity in the complex treatment of pediatric hydrocephalus. Over the last decade, adjustable serial valves have gradually replaced fixed-pressure valves in the authors' department. The present study investigates this development by analyzing shunt- and valve-related outcomes for this vulnerable population. A retrospective analysis of all shunting procedures between January 2009 and January 2021 in children younger than 1 year of age was performed at the authors' single-center institution. Postoperative complications and surgical revisions were set as outcome parameters. Shunt and valve survival rates were evaluated. Statistical analysis compared children who underwent implantation of the Miethke proGAV/proSA programmable serial valves with those who underwent implantation of the fixed-pressure Miethke paediGAV system. Eighty-five procedures were evaluated. The paediGAV system was implanted in 39 cases and the proGAV/proSA in 46 cases. The mean ± SD follow-up was 247.7 ± 140 weeks. In 2009 and 2010, paediGAV valves were used exclusively, but by 2019, the use of proGAV/proSA had evolved into the first-line therapy. The paediGAV system was significantly more often revised (p < 0.05). The main indication for revision was proximal occlusion, with or without impairment to the valve. The valve and shunt survival rates of proGAV/proSA were significantly prolonged (p < 0.05). The surgery-free valve survival of proGAV/proSA was 90% after 1 year and 63% after 6 years. There were no overdrainage-related revisions of proGAV/proSA valves. Favorable shunt and valve survival validates the increasing use of programmable proGAV/proSA serial valves in this delicate population. Potential benefits in postoperative treatment should be addressed in prospective multicenter studies.

Characterizing the Accuracy of International Classification of Diseases, Tenth Revision Administrative Claims for Aortic Valve Disease.

Administrative claims for aortic stenosis (AS) regurgitation may be useful, but their accuracy and ability to identify individuals at risk for valve-related outcomes have not been well characterized. Using echocardiographic (transthoracic echocardiogram [TTE]) reports linked to US Medicare claims, 2017 to 2018, the performance of candidate International Classification of Diseases, Tenth Revision claims to ascertain AS/aortic regurgitation was evaluated. The optimal performing algorithm was tested against outcomes at 1-year after TTE in a separate 100% sample of US Medicare claims, 2017 to 2019. Of those included in the derivation (N=5497, mean age 74.4±11.0 years, 49.7% female), any AS or aortic regurgitation was present in 24% and 38.8%, respectively. The sensitivity and specificity of International Classification of Diseases, Tenth Revision code I35.0 for identification of any AS was 53.1% and 94.8%, respectively. Among those with an I35.0 code, 40.3% had severe AS. Claims were unable to distinguish disease severity (ie, severe versus nonsevere) or subtype (eg, bicuspid or rheumatic AS), and were insensitive and nonspecific for aortic regurgitation of any severity. Among all beneficiaries who received a TTE (N=4 033 844), adjusting for age, sex, and 27 comorbidities, those with an I35.0 code had a higher adjusted risk of all-cause mortality (adjusted hazard ratio, 1.33 [95% CI, 1.31-1.34]), heart failure hospitalization (adjusted hazard ratio, 1.37 [95% CI, 1.34-1.41]), and aortic valve replacement (adjusted hazard ratio, 34.96 [95% CI, 33.74-36.22]). Among US Medicare beneficiaries receiving a TTE, International Classification of Diseases, Tenth Revision claims, though identifying a population at significant greater risk of valve-related outcomes, failed to identify nearly half of individuals with AS and were unable to distinguish disease severity or subtype. These results argue against the widespread use of International Classification of Diseases, Tenth Revision claims to screen for patients with AS and suggests the need for improved coding algorithms and alternative systems to extract TTE data for quality improvement and hospital benchmarking.

Mitral valve surgery after failed MitraClip-Operation for the inoperable?

Percutaneous edge-to-edge mitral valve repair technique (MitraClip) is a widely used treatment for mitral regurgitation (MR) in patients assessed with high surgical risk or inoperability. Only limited experiences with this highest-risk patient population exist. Procedural failure for MitraClip or recurrent MR is a strong predictor of 1-year mortality. Open mitral valve surgery constitutes the last bailout for patients within this cohort. This retrospective single-center cohort study analyzed 17 mitral valve surgery patients after failed MitraClip. We, therefore, analyzed a high-risk patient population (EuroSCOREII = 10 ± 2.0) with persistent mitral valve regurgitation, which was mainly caused by detachment or dislocation of the MitraClip. Symptomatic patients with failed MitraClip need a convenient operation (mean time to mitral valve surgery = 23 ± 44 days). The patient's collective showed many complex reoperations with the need for concomitant surgery. Considering the high-risk patient population, we showed an average 30-day all-cause mortality (18%, n = 3) accompanied by typical postoperative complications related to prolonged mechanical ventilation (44 ± 48 h) and ICU stay (11 ± 11 days), reflecting high-risk patients. Further, excellent valve-related outcomes were shown regarding adverse cardiac events (valve-related mortality 6%, n = 1) and postoperative echocardiographic results (moderate or severe paravalvular leak 6%, n = 1). Failure of MitraClip represents a challenging situation limited by high-risk profiles of patients and limits the possibility of surgical valve repair, shown by a high rate of mitral valve replacement (94%, n = 16). Secondary surgery was associated with moderate 30-day and postdischarge outcomes. Therefore, a careful evaluation of patients undergoing MitraClip is of paramount importance.

Durability of Bioprosthetic Valves in Patients on Dialysis.

This study focused on clarifying the durability of bioprosthetic valves in current practice. A total of 238 consecutive patients who underwent aortic valve replacement at a single institution from 2011 to 2020 were reviewed. We evaluated valve-related outcomes such as structural valve deterioration (SVD), especially in dialysis patients who received bioprosthetic valve. Among the tissue valves implanted in 212 patients, 5 SVDs were recorded and 3 valves were replaced. All early valve failures occurred in relatively young dialysis patients and were recorded 3 to 5 years after the initial operation. Freedom from SVD at 6 years was 49.9% in patients on dialysis, compared with 100% in non-dialysis patients. Predictors of better survival in dialysis patients were better preoperative functional class and larger prosthetic valve size. The durability of bioprosthetic valves in the aortic position was suboptimal in dialysis patients. Mechanical valves can be an option for young, healthy dialysis patients with a large aortic valve annulus.

Outcomes following bioprosthetic valve replacement in prior non-cardiac transplant recipients.

We report on overall survival and valve-related outcomes after bioprosthetic valve replacement in prior transplant recipients. From January 2004 to December 2018, 20 consecutive patients (mean age 65.7-years, 90% male) with prior non-cardiac transplantation underwent bioprosthetic aortic (n=18) or combined aortic and mitral (n=2) valve replacement. Patients consisted of kidney (n=14), lung (n=2), liver (n=3), and bone-marrow (n=2) transplants with the most common indication for valve replacement being calcific degeneration (n=12). Outcomes were measured over a 12-year span, with a median follow-up duration of 3.9years. Overall survival at 30days was 100% and at median follow-up was 60%. Acute kidney injury occurred in 50% (n=10) with temporary dialysis required in 5% (n=1) and 15% (n=3) suffered respiratory failure. No patients experienced major bleeding, heart failure, or sternal wound infection. No patients required redo valve replacement during the study period. Our results provide contemporary data demonstrating that patients with prior transplant can undergo bioprosthetic valve replacement with acceptable inhospital mortality rates and long-term survival, with a low rate of major morbidity. Furthermore, bioprosthetic valve replacement is a viable option in this group of patients with no redo valve replacement and acceptable long-term hemodynamic valvular function.

Mid-Term Valve-Related Outcomes After Transcatheter Tricuspid Valve-in-Valve or Valve-in-Ring Replacement

BackgroundTranscatheter aortic and pulmonary valves have been used to treat stenosis or regurgitation after prior surgical tricuspid valve (TV) replacement or repair. Little is known about intermediate-term valve-related outcomes after transcatheter tricuspid valve replacement (TTVR), including valve function, thrombus, and endocarditis. ObjectivesThe authors sought to evaluate mid-term outcomes in a large cohort of patients who underwent TTVR after surgical TV repair or replacement, with a focus on valve-related outcomes. MethodsPatients who underwent TTVR after prior surgical TV replacement or repair were collected through an international registry. Time-related outcomes were modeled and risk factors assessed. ResultsData were collected for 306 patients who underwent TTVR from 2008 through 2017 at 80 centers; 52 patients (17%) had a prior history of endocarditis. Patients were followed for a median of 15.9 months after implantation (0.1 to 90 months), with 64% of patients estimated to be alive without TV reintervention or a valve-related event at 3 years. The cumulative 3-year incidence of death, reintervention, and valve-related adverse outcomes (endocarditis, thrombosis, or significant dysfunction) were 17%, 12%, and 8%, respectively. Endocarditis was diagnosed in 8 patients 2 to 29 months after TTVR, for an annualized incidence rate of 1.5% per patient-year (95% confidence interval: 0.45% to 2.5%). An additional 8 patients were diagnosed with clinically relevant valve thrombosis, 3 in the short term, 2 within 2 months, and 3 beyond 6 months. Only 2 of these 8 patients received anticoagulant therapy before thrombus detection (p = 0.13 vs. patients without thrombus). Prior endocarditis was not a risk factor for reintervention, endocarditis, or valve thrombosis, and there was no difference in valve-related outcomes according to TTVR valve type. ConclusionsTV dysfunction, endocarditis, and leaflet thrombosis were uncommon after TTVR. Patients with prior endocarditis were not at higher risk for endocarditis or other adverse outcomes after TTVR, and endocarditis occurred with similar frequency in different valve types. Though rare, leaflet thrombosis is an important adverse outcome, and further study is necessary to determine the appropriate level of prophylactic therapy after TTVR.

Outcomes of Valve Repair for Degenerative Disease in Patients With Mitral Annular Calcification

The risk factors for the development of mitral annular calcification (MAC) in degenerative mitral valve disease and the effect it may have on patient-and valve-related outcomes require further evaluation. Between January 2002 and December 2015, 627 patients underwent mitral valve operations for degenerative disease. MAC was seen in 75 patients (12%); 73 (97%) underwent valve repair (6 without annuloplasty ring implantation) and 2 (3%) underwent valve replacement after an unsuccessful repair attempt. MAC was linked to patient age, female sex, and degenerative disease subtype. Early mortality was comparable between patients with and without MAC (3 of 75 [4%] vs 10 of 552 [2%], p= 0.20]. In patients with MAC, one-third of the deaths were directly related to annular decalcification and reconstruction. Early repair failure was more common in patients with MAC (8 of 75 [11%] vs 17 of 552 [3%], p= 0.006). During follow-up, no differences in overall survival or freedom from late reintervention were observed. However, at 8 years after the operation, freedom from recurrent mitral regurgitation was worse in patients with MAC. In these patients, repair failure was linked to nonuse of ring annuloplasty. For patients with MAC in whom annular decalcification and annuloplasty were performed, repair durability was comparable to patients without MAC. Mitral valve surgery in degenerative disease accompanied by MAC is safe. Optimal surgical strategy includes annular decalcification (when this would prevent implantation of an annuloplasty ring) and ring annuloplasty and will lead to results similar to patients without MAC. However, repair performance is hampered when the annulus is not addressed. For these patients, alternative repair techniques should be explored in the future.

Medtronic Duran AnCore versus Edwards MC3 rings for tricuspid annuloplasty.

Ring annuloplasty is now regarded as the standard surgical technique for the correction of tricuspid regurgitation (TR). However, comparative research on the durability of commercially available annuloplasty rings is limited. We reviewed early and late surgical results of tricuspid annuloplasty using the Duran AnCore and Edwards MC3 rings. From our institutional prospective cardiac surgical database, we identified 581 adult patients (55.9 ± 12.9 years) undergoing tricuspid ring annuloplasty using either a Duran AnCore ( n = 370; Duran group) or an Edwards MC3 ring ( n = 211; MC3 group) from January 2001 through December 2012. Survival rates, valve-related outcomes and late tricuspid functions were compared between the 2 groups. Propensity score analysis was conducted to adjust for selection bias. The degree of TR assigned preoperatively was mild in 128 (22.0%), moderate in 205 (35.3%), and severe in 248 patients (42.7%), with a higher prevalence of severe TR in the Duran group than in the MC3 group (46.5% vs 36.0%; P = 0.014). Over an observation period of 47.0 months, 46 patients developed significant TR (≥ moderate). After propensity score matching, there were no significant differences in the risks of early mortality ( P = 0.36), early complications ( P > 0.99) and recurrence of significant TR ( P = 0.33). Both the Duran and the MC3 rings showed comparable safety and tricuspid valve durability for tricuspid valve annuloplasty.

Valve Selection for the Aortic Position in Dialysis Patients

Prosthetic valve selection in dialysis patients remains controversial because of the limited data available. This study aimed to clarify late clinical outcomes and discuss strategies for optimal valve selection in dialysis patients. We retrospectively analyzed the data obtained from 406 consecutive patients who underwent aortic valve replacement between 1995 and 2010. We compared valve-related outcomes among 89 dialysis and 317 nondialysis patients. We selected bioprostheses for all patients older than 65 to 70 years, irrespective of the renal function. Dialysis was found to be a significant risk factor for bleeding events (hazard ratio, 3.98; 95% confidence interval, 2.51 to 6.30; p < 0.001), however, no significant differences were observed according to the type of prosthesis. The overall survival was significantly worse in the dialysis patients (63% versus 85% at 5 years; p < 0.001), and freedom from structural valve deterioration was also lower in the dialysis patients (82% versus 100% at 5 years; p < 0.001). Among the dialysis patients, an advanced age (≥ 70 years; hazard ratio, 3.53; p = 0.011), diabetes mellitus (hazard ratio, 2.48; p = 0.041), and concomitant coronary artery bypass grafting (hazard ratio, 1.99; p = 0.071) were independent predictors for late death based on a multivariate analysis. Our valve selection criteria in dialysis patients, which are the same as the current practice guidelines for nondialysis patients, are acceptable. Bioprostheses can be considered in all dialysis patients with diabetes or coronary artery disease.

Mid- to long-term aortic valve-related outcomes after conventional repair for patients with interrupted aortic arch or coarctation of the aorta, combined with ventricular septal defect: the impact of bicuspid aortic valve

Bicuspid aortic valve (BAV) is a common risk factor for valve-related problems and occurs more frequently in patients with an interrupted aortic arch (IAA) or coarctation of the aorta (CoA), combined with a ventricular septal defect (VSD), than in the general population. We have been using conventional repair for patients with IAA/CoA+VSD, including those with a very small aortic valve (AV). We retrospectively investigated the outcomes of these patients from the perspective of valve morphology. Between 2000 and 2012, 50 consecutive patients underwent conventional repair for CoA/IAA with VSD [one-stage repair, 44 (88%); staged repair, 6 (12%)]. The criteria for conventional repair were as follows: an AV annulus diameter (AVD) z-score of >-6.0; mitral valve annulus diameter z-score of >-3.0; without retrograde flow in the proximal arch. Sixteen (32%) patients had BAV (Group B); the remaining 34 (68%) patients had a tricuspid AV (Group T). The surgical outcomes in both groups were investigated. No mortality occurred in the cohort. The median follow-up times were 6 years and 3 months (6 months to 11 years and 8 months) and 6 years and 2 months (4 months to 11 years and 4 months) in Groups B and T, respectively (P > 0.05). The preoperative data (median age at repair, median body weight and median AVD) were comparable in the two groups (P > 0.05). Two patients (4%) underwent reintervention in the aortic arch: 1 patient underwent balloon angioplasty for re-coarctation; the other removal of the interposed graft because of somatic growth. In both groups, the AVD became significantly larger at the 1-year follow-up, approximating the normal value. Three (6%) patients underwent a total of eight valve-related reinterventions (balloon angioplasty, 6; Ross operation, 1; valve replacement, 1). All three had BAV, and the AVD was 3.8-5.6 mm (z-score, -3.4 to -1.6). The 5-year valve-related reintervention-free survival rate was 76% and 100% in Groups B and T, respectively (P < 0.01). The long-term outcomes after conventional repair under our criteria were acceptable. BAV was a significant risk factor for valve-related reinterventions after conventional repair for IAA/CoA with VSD.

Should bioprostheses be considered the valve of choice for dialysis-dependent patients?

BackgroundThere is controversy regarding the choice of prosthetic valves in patients with cardiac valve disease and dialysis-dependent patients. This review assesses a 12-year experience and outcomes after valve replacement in patients on chronic preoperative renal dialysis, comparing survival and valve-related outcomes following valve replacement with bioprostheses versus mechanical prostheses in this population in china.MethodsFrom January 1999 and October 2011, 73 consecutive dialysis patients underwent cardiac valve replacement. The patients were divided into two groups: (Group B) bioprosthesis valves were implanted in 38 (52.1%) patients and (Group M) mechanical valves were implanted in 35 (47.9%) patients. Outcome measures included perioperative data, hospital mortality, major postoperative complications, follow-up outcomes, valve related morbidity and late survival.ResultsThere were no significant differences in terms of patient characteristics in the 2 groups. Thirty-three were isolated aortic valve replacements (45.2%); 28 were isolated mitral valve replacements (38.4%); 10 were combined aortic and mitral replacements (13.7%); 2 were combined tricuspid and mitral replacements (2.7%). The overall hospital mortality was 5.5% (n = 4) and was not different between Group B (5.3%) and Group M (5.7%). Low ejection fraction was the only independent predictors of hospital mortality. There was no significant difference between the groups in the overall rate of complications. The overall mean follow-up was 47 ± 23 months. According to the Kaplan-Meier analysis, late mortality, perivalvular leak and freedom from reoperation were similar in patients with mechanical and bioprosthesis valves. The bioprosthesis valve group had significantly higher freedom from thromboembelism-bleeding events (100% versus 77.6 ± 11.0%, p = 0.012), and valve-related morbidity (73.2 ± 10.1% versus 58.1 ± 10.9%, p = 0.035) in 5 years. Kaplan–Meier survival estimates at 1, 3, and 5 years were 0.971, 0.832, and 0.530 in group B, and 0.967, 0.848, and 0.568 in group M.ConclusionsThere is no significant difference in the perioperative morbidity and mortality, late survival of dialysis patients after cardiac valve replacement with bioprostheses versus mechanical valves. In spite of the limited sample size analyzed, its outcome and consistency to several previous reports supports a conclusion that bioprostheses rather than mechanical ones could be a favorable choice for valve replacement needs of renal failure patients.

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Risk of Valve-Related Events After Aortic Valve Repair

The impetus for aortic valve (AV) repair is to decrease valve-related complications in comparison to prosthetic valve replacement. However, relatively few data are available to confirm this hypothesis. We analyzed valve-related complications in a large series of patients undergoing AV repair. Between 1995 and 2010, 475 patients underwent elective AV repair for aortic insufficiency or aortic aneurysm. The mean age was 53 years, and 81% were male. Valve-related outcomes were defined as per published guidelines. Survival and freedom from valve-related events were reported using the Kaplan-Meier method and linearized event rates. Clinical follow-up was 98.3% complete with a mean follow-up time of 4.6 years. Thirty-day mortality was 0.8% (n = 4). At 10 years, overall survival was 73% ± 5%, freedom from cardiac death was 81% ± 4%, and freedom from valve-related death was 90% ± 3%. Freedom from significant aortic insufficiency was 84% ± 3%. A total of 28 patients needed early (n = 7) or late (n = 21) AV reoperation; all of them survived reoperation, and 8 had repeat repair. Ten-year freedom from AV reoperation was 86% ± 3%, and freedom from AV replacement was 90% ± 3%. Freedom from AV reoperation was similar in tricuspid and bicuspid valve. During the follow-up period, linearized rate of thromboembolic event, bleeding, and AV endocarditis was 1.1%, 0.23%, and 0.19% per year, respectively. Ten-year freedom from valve-related events including AV reoperation, thromboembolic event, bleeding, and endocarditis was 74% ± 3%. The current findings confirm that AV repair is associated with low mortality, acceptable durability, and a low risk of valve-related events.

Microsimulation and clinical outcomes analysis support a lower age threshold for use of biological valves

ObjectiveTo characterise contemporary results of aortic valve replacement in relation to type of prosthesis and subsequent competing hazards.Methods5470 procedures in 5433 consecutive patients with aortic valve replacement ± coronary artery...