Survival affects decision making for fenestrated and branched endovascular aortic repair.

OBJECTIVE: Repair options for complex abdominal and thoracoabdominal aortic aneurysms (TAAAs) are evolving with increased experience and availability of less invasive endovascular techniques. Identifying risk factors for mortality after fenestrated and branched endovascular aortic repair (F/B-EVAR) could improve patient selection and facilitate decision making regarding who may benefit from prophylactic F/B-EVAR. METHODS: We evaluated 1091 patients in a prospective investigational device exemption trial who underwent F/B-EVAR from August 2001 to June 2015 for complex aortic aneurysms (CAAs). Multivariable analysis of risk factors for death was performed using a nonproportional hazards model and a nonparametric analysis using random survival forest technology. RESULTS: Operative mortality after F/B-EVAR was low (3.7%), with high CAA-related survival at 30 day and 5 years (96.8% and 94.0%, respectively). All-cause 5-year survival, however, was 46.2% and older age, heart failure, chronic obstructive pulmonary disease, renal disease, anemia, and coagulation disorders were risk factors. Risk was highest for those undergoing type I/II TAAA repairs and those with larger aneurysms. CONCLUSIONS: Patients with multiple comorbidities and those undergoing type I or II TAAA repair are at greatest risk of mortality; however, in this high-risk population, F/B-EVAR offers greater survival compared with that reported for the natural history of untreated aneurysms. Operative and early mortality is lower than the best-reported open repair outcomes, even in this high-risk population, suggesting a potential benefit in extending the use of F/B-EVAR to low-to-average risk CAA patients.

Estimating the prevalence of atrial fibrillation from a three-class mixture model for repeated diagnoses.

Atrial fibrillation (AF) is an abnormal heart rhythm characterized by rapid and irregular heartbeat, with or without perceivable symptoms. In clinical practice, the electrocardiogram (ECG) is often used for diagnosis of AF. Since the AF often arrives as recurrent episodes of varying frequency and duration and only the episodes that occur at the time of ECG can be detected, the AF is often underdiagnosed when a limited number of repeated ECGs are used. In studies evaluating the efficacy of AF ablation surgery, each patient undergoes multiple ECGs and the AF status at the time of ECG is recorded. The objective of this paper is to estimate the marginal proportions of patients with or without AF in a population, which are important measures of the efficacy of the treatment. The underdiagnosis problem is addressed by a three-class mixture regression model in which a patient's probability of having no AF, paroxysmal AF, and permanent AF is modeled by auxiliary baseline covariates in a nested logistic regression. A binomial regression model is specified conditional on a subject being in the paroxysmal AF group. The model parameters are estimated by the Expectation-Maximization (EM) algorithm. These parameters are themselves nuisance parameters for the purpose of this research, but the estimators of the marginal proportions of interest can be expressed as functions of the data and these nuisance parameters and their variances can be estimated by the sandwich method. We examine the performance of the proposed methodology in simulations and two real data applications.

Propensity-matched comparisons of clinical outcomes after transapical or transfemoral transcatheter aortic valve replacement: a placement of aortic transcatheter valves (PARTNER)-I trial substudy.

BACKGROUND: The higher risk of adverse outcomes after transapical (TA) versus transfemoral (TF) transcatheter aortic valve replacement (TAVR) could be attributable to TA-TAVR being an open surgical procedure or to clinical differences between TA- and TF-TAVR patients. We compared outcomes after neutralizing patient differences using propensity score matching. METHODS AND RESULTS: From April 2007 to February 2012, 1100 Placement of Aortic Transcatheter Valves (PARTNER)-I patients underwent TA-TAVR and 1521 underwent TF-TAVR with Edwards SAPIEN balloon-expandable bioprostheses. Propensity matching based on 111 preprocedural variables, exclusive of femoral access morphology, identified 501 well-matched patient pairs (46% of possible matches), 95% of whom had peripheral arterial disease. Matched TA-TAVR patients experienced more adverse procedural events, longer length of stay (5 versus 8 days; P<0.0001), and slower recovery (New York Heart Association class I, 31% versus 38% at 30 days, equalizing by 6 months at 51% versus 47%); stroke risk was similar (3.4% versus 3.3% at 30 days and 6.0% versus 6.7% at 3 years); mortality was elevated for the first 6 postprocedural months (19% versus 12%; P=0.01); but aortic regurgitation was less (34% versus 52% mild and 8.9% versus 12% moderate to severe at discharge, P=0.001; 36% versus 50% mild and 10% versus 15% moderate to severe at 6 months, P<0.0001). CONCLUSIONS: The likelihood of adverse periprocedural events and prolonged recovery is greater after TA-TAVR than TF-TAVR in vasculopathic patients after accounting for differences in cardiovascular risk factors, although stroke risk is equivalent and aortic regurgitation is less. As smaller delivery systems permit TF-TAVR in many of these patients, we recommend a TF-first access strategy for TAVR when anatomically feasible. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance.

OBJECTIVES: To assess technical performance learning curves of teams performing transfemoral transcatheter aortic valve replacement (TF-TAVR). BACKGROUND: TF-TAVR is a new procedure for treating severe aortic stenosis. The number of cases required for procedural efficiency is unknown. METHODS: In the PARTNER-I trial, 1,521 patients underwent TF-TAVR from 4/2007-2/2012. Learning curve analysis of technical performance metrics was performed using institution-specific patient sequence number, interval between procedures, and institutional trial entry date. Learning curve characteristics were assessed using semi-parametric and parametric mixed-effects models. RESULTS: As patient sequence number increased, average procedure time decreased from 154 to 85 minutes (P < 0.0001), and fluoroscopy time from 28 to 20 minutes (P < 0.0001). Procedure time plateaued at an average of 83 minutes (range 52-140). Procedure time plateau was dynamic during the course of the trial, averaging 25 cases (range 21-52) by its end. The later institutions enrolled in the trial, the shorter the initial procedure time. During the trial, percutaneous rather than surgical access increased from 7.9% to 69%. CONCLUSIONS: Technical performance learning curves exist for TF-TAVR; procedural efficiency increased with experience, with concomitant decreases in radiation and contrast media exposure. The number of cases needed to achieve efficiency decreased progressively, with optimal procedural performance reached after approximately 25 cases for late-entering institutions. Knowledge and experience accumulated by early TF-TAVR institutions were disseminated, shortening the learning curve of late-entering institutions. Technological advances resulting from learning during the trial moved the field from initial conservative surgical cut-down to percutaneous access for most patients. © 2015 Wiley Periodicals, Inc.

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.

OBJECTIVES: To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve. BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes. METHODS: From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay. RESULTS: Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6). CONCLUSIONS: By end of trial, a consistent low risk of adverse events was achieved after ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.

Tricuspid regurgitation and implantable devices.

BACKGROUND: There are limited and conflicting data regarding the prevalence of tricuspid regurgitation (TR) after cardiac device implantation (implantable cardioverter defibrillator [ICD]; permanent pacemaker [PPM]). OBJECTIVE: The goal of this study was to assess the prevalence of TR after cardiac device implantation and determine its clinical significance. METHODS: A total of 1,596 patients, who had cardiac devices implanted between 2005 and 2011 at the Cleveland Clinic and had at least one preimplantation echocardiogram and at least one postimplantation echocardiogram were included in this study. A total of 3,566 postimplantation echocardiograms were available for the 1,596 patients (median follow-up 10 months). The primary end point was postimplantation TR and the secondary end point was all-cause mortality after implantation. We have used a cumulative logistic nonlinear mixed-effects model to assess the temporal trend of TR prevalence and a parametric multiphase hazard model to assess survival. RESULTS: Of the 1,596 patients (mean age: 60 ± 10 years, 61% of patients were men), 985 (62%) had ICDs (including 334 patients with cardiac resynchronization therapy defibrillator) and 611 (38%) had PPMs. The prevalence of grade 3 or 4+ TR increased from 27% to 31% by 1 month and to 35% at 4 years. Accordingly, prevalence of grade 0/1+ TR decreased from 46% preimplantation to 37% at 1 month and to 32% at 4 years. Device type (ICD vs PPM) and the number of leads placed did not have an effect on postimplantation TR (P > 0.2). Right ventricular systolic pressure (RVSP) did not change over time (36 mm Hg baseline, 37.5 mm Hg by 3 months, and 37 mm Hg by 1 year). One-year and 5-year survival were 93% and 73%, respectively. Postimplantation TR was an independent risk factor for late death (P < 0.05). CONCLUSION: Cardiac device implantation was associated with a small but significant increase in the prevalence of moderate and severe TR, both acutely and chronically after implantation. The increase in TR was similar with both ICD and PPM placement, which was not related to the number of leads implanted and not associated with a significant increase in RVSP. Postimplantation TR was associated with a higher risk of mortality.

The natural history of lung function after lung transplantation for α(1)-antitrypsin deficiency.

RATIONALE: Lung transplantation (LT) is an established treatment for end-stage lung diseases, including chronic obstructive pulmonary disease (COPD) associated with α1-antitrypsin deficiency (AATD). OBJECTIVES: We sought to compare the post-transplantation course of patients with AATD and AAT-replete COPD. METHODS: Between June 1991 and January 2008, a total of 231 patients with AAT-replete COPD and 45 with AATD underwent LT at Cleveland Clinic. Data reviewed included baseline recipient, donor, and surgical data; all spirometry evaluations; acute cellular rejection (ACR) events; and survival data. Endpoints included temporal change in FEV1, severity of ACR, and survival. A longitudinal temporal decomposition model was used for analysis. MEASUREMENTS AND MAIN RESULTS: Comparison of overall rates of FEV1 decline in AATD and AAT-replete patients with COPD showed no significant differences (P > 0.09). However, although the single LT patients had similar trends in FEV1 in both groups, patients with AATD with double LT declined faster (P < 0.002) than the AAT-replete patients. No differences in the frequency or severity of ACR episodes were observed (P = 0.32). Furthermore, there was no difference in early or late mortality between patients with AATD and patients with AAT-replete COPD (P > 0.09). CONCLUSIONS: Although overall the post-LT FEV1 slope, severity of ACR, and survival among patients with AATD is similar to that of AAT-replete patients with COPD, patients with AATD with double LT have a faster rate of FEV1 decline. These findings support the eligibility of patients with AATD for LT, and suggest the need for additional studies to better understand the difference between single and double LT in AATD.

Outcomes of aortic root replacement with tricuspid aortic valve reimplantation in patients with residual aortic regurgitation.

OBJECTIVE: To characterize residual aortic regurgitation (AR), identify its risk factors, and evaluate outcomes following aortic root replacement with aortic valve reimplantation. METHODS: From 2002 to 2020, 756 patients with a tricuspid aortic valve underwent elective reimplantation for aortic root aneurysm. AR on transthoracic echocardiograms before hospital discharge was graded as mild or greater. Machine learning was used to identify risk factors for residual AR and subsequent aortic valve reoperation. RESULTS: Sixty-five patients (8.6%) had mild (58 [7.7%]) or moderate (7 [0.93%]) residual postoperative AR. They had more severe preoperative AR (38% vs 12%; P < .0001), thickened cusps (7.7% vs 2.2%; P = .008), aortic valve repair (38% vs 23%; P = .004), and multiple returns to cardiopulmonary bypass for additional repair (11% vs 3.3%; P = .003) than those without AR. Predictors of residual AR were severe preoperative AR, smaller aortic root graft, and concomitant cusp repair. At 10 years, patients with versus without residual AR had more moderate or severe AR (48% vs 7.0%; P < .0001) and freedom from reoperation was worse (89% vs 98%; P < .0001). Residual AR was a risk factor for early reoperation. Concomitant coronary bypass, lower body mass index, and lower ejection fraction were risk factors for late reoperation. Ten-year survival was similar among patients with and without residual AR (97% vs 93%; P = .43). CONCLUSIONS: Residual AR after elective reimplantation of a tricuspid aortic valve for aortic root aneurysm is uncommon. Patients with severe preoperative AR and those who undergo valve repair have higher risk for residual AR, which can progress and increase risk of aortic valve reoperation.

Long-term outcome of bicuspid aortic valve repair using figure-of-8 hitch-up stitches.

Objective: To maximize successful repair of bicuspid aortic valves by adding figure-of-8 hitch-up stitches at commissures. Methods: From 2000 to 2022, bicuspid aortic valve repair was performed on 1112 patients at Cleveland Clinic, with 367 patients receiving figure-of-8 hitch-up stitches along with classical techniques, including Cabrol suture, cusp plication, raphe resection, and valve-sparing root replacement. Operative outcomes, repair durability, and survival were assessed in the figure-of-8 hitch-up stitches cohort, and outcomes were compared among 195 balancing-score-matched patient pairs who underwent bicuspid aortic valve repair with and without figure-of-8 hitch-up stitches. Results: Patients who underwent bicuspid aortic valve repair with figure-of-8 stitches had an operative mortality of 0.3% (1 of 367) and in-hospital reoperation for aortic valve dysfunction of 1.1% (4 of 367). At 10 years, prevalence of severe aortic regurgitation was 8.6%, mean gradient 24 mm Hg, freedom from aortic valve reoperation 75%, and survival 98%. In matched cohorts, operative mortality was similar (0.51% vs 0%; P > .9) as were morbidities, including in-hospital reoperation due to aortic valve dysfunction (1.0% vs 1.5%; P > .9). Comparable long-term outcomes were observed at 10 years (prevalence of severe aortic regurgitation of 8.7% vs 5.0% [P = .11], mean gradient 18 vs 17 mm Hg [P = .40]; freedom from aortic valve reoperation 80% vs 81% [P = .73]; and survival 99.5% vs 94.6% [P = .18]). Conclusions: Figure-of-8 hitch-up stitch is a safe bicuspid aortic valve repair technique. It increases the likelihood of a successful repair without increasing risk of cusp tear and achieves satisfactory long-term survival and durability when added to classical repair techniques.

The Ozaki Procedure: Standardized Protocol Adoption of a Complex Innovative Procedure.

Background: The Ozaki procedure using autologous pericardium is an interesting but complex alternative for aortic valve replacement. We present a standardized approach to minimize the learning curve and confirm reproducibility. Methods: After careful preparation, from May 2015 to February 2021, an Ozaki procedure was performed on 46 patients age 51 ± 14 years. Seven had unicuspid (15%), 29 bicuspid (63%), and 10 tricuspid (22%) aortic valves, and 2 patients had endocarditis. Endpoints were operative learning curves, perioperative outcomes, intermediate-term valve hemodynamics, reintervention, health-related quality of life (MacNew Heart Disease Health-Related Quality of Life questionnaire), and mortality. Results: Cardiopulmonary bypass and aortic clamp times decreased from 145 to 125 â€‹minutes and 120 to 100 â€‹minutes, respectively, over the first 20 cases, reflecting the learning curve. There was no major perioperative morbidity or mortality. Median postoperative stay was 6.9 days. Aortic regurgitation was mild or less in all but 2 patients who developed moderate aortic regurgitation. Mean aortic valve gradient was 7.9 mmHg postoperatively, 9.2 mmHg by 6 months, and constant thereafter. Left ventricular ejection fraction was 58% preoperatively, 60% at 6 months, and remained stable thereafter. One patient developed infective endocarditis 7 months postoperatively, failed medical management, and underwent valve replacement at 14 months. Two-year survival was 96%, with 1 noncardiac death at 16 months. Health-related quality of life in mental, physical, and emotional domains was better than matched norms, global 6.2 vs. 5.0 (p < 0.0001). Conclusions: Using a well-prepared standardized approach, the Ozaki procedure is reproducible with a short learning curve, excellent hemodynamic performance, and good quality of life.

Contemporary experience with the Commando procedure for anterior mitral anular calcification.

Objective: Anterior mitral anular calcification, particularly in radiation heart disease, and previous valve replacement with destroyed intervalvular fibrosa are challenging for prosthesis sizing and placement. The Commando procedure with intervalvular fibrosa reconstruction permits double-valve replacement in these challenging conditions. We referenced outcomes after Commando procedures to standard double-valve replacements. Methods: From January 2011 to January 2022, 129 Commando procedures and 1191 aortic and mitral double-valve replacements were performed at the Cleveland Clinic, excluding endocarditis. Reasons for the Commando were severe calcification after radiation (n = 67), without radiation (n = 43), and others (n = 19). Commando procedures were referenced to a subset of double-valve replacements using balancing-score methods (109 pairs). Results: Between balanced groups, Commando versus double-valve replacement had higher total calcium scores (median 6140 vs 2680 HU, P = .03). Hospital outcomes were similar, including operative mortality (12/11% vs 8/7.3%, P = .35) and reoperation for bleeding (9/8.3% vs 5/4.6%, P = .28). Survival and freedom from reoperation at 5 years were 54% versus 67% (P = .33) and 87% versus 100% (P = .04), respectively. Higher calcium score was associated with lower survival after double-valve replacement but not after the Commando. The Commando procedure had lower aortic valve mean gradients at 4 years (9.4 vs 11 mm Hg, P = .04). After Commando procedures for calcification, 5-year survival was 60% and 59% with and without radiation, respectively (P = .47). Conclusions: The Commando procedure with reconstruction of the intervalvular fibrosa destroyed by mitral anular calcification, radiation, or previous surgery demonstrates acceptable outcomes similar to standard double-valve replacement. More experience and long-term outcomes are required to refine patient selection for and application of the Commando approach.

Characterizing the anatomic spectrum, surgical treatment, and long-term clinical outcomes for patients with Shone's syndrome.

OBJECTIVE: Shone's syndrome (SS) has a varied anatomic spectrum without consensus on need and timing for mitral valve intervention (MVI). We sought to (1) characterize the anatomic spectrum and treatment pathways; (2) describe long-term outcomes and their determinants; and (3) define the impact of MVI timing on survival. METHODS: In total, 121 patients with SS who underwent operation at Cleveland Clinic between 1956 and 2021 were reviewed. Multivariable parametric hazard analyses including time-varying covariables, and modulated renewal to account for repeated events, were performed. End points included time-related survival and reintervention. RESULTS: Median follow-up was 9.9 years. Mitral stenosis (MS) (98%), coarctation (80%), and aortic stenosis (70%) predominated. The most common combination was MS + aortic stenosis + coarctation (26%). Median initial mean mitral and aortic gradients were 3.6 (15th/85th percentiles: 2.0/6.8) and 9.0 (2.1/46) mm Hg, respectively. Median initial surgery age was 0.041 (0.011/3.2) years. Initial surgeries included coarctation repair (43%), arch repair (18%), and staged biventricular repair (18%). Overall survival was 92% at 20 years. Freedom from reoperation was 66% and 24% at 1 and 20 years. Patients with no MVI or initial MVI (N = 7) tended to be associated with better early survival compared with those with MVI at subsequent operation (N = 29) (P = .06). Risk factors for early reintervention included initial Norwood operation, with younger age and arch hypoplasia increasing later reintervention. CONCLUSIONS: Despite excellent long-term survival, reoperation in SS is frequent and occurs most commonly on left ventricular outflow tract and mitral valve. Although MS is present in most, few require MVI. Delaying MVI may compromise early survival.

The decreasing risk of reoperative aortic valve replacement: Implications for valve choice and transcatheter therapy.

OBJECTIVE: Increasing use of bioprostheses for surgical aortic valve replacement (SAVR) in younger patients, together with wider use of transcatheter aortic valve replacement, necessitates understanding risks associated with surgical valve reintervention. Therefore, we sought to identify risks of reoperative SAVR compared with those of primary isolated SAVR. METHODS: From January 1980 to July 2017, 7037 patients underwent nonemergency isolated SAVR, with 753 reoperations and 6284 primary isolated operations. These 2 groups were propensity score-matched on 46 preoperative variables, yielding 581 patient pairs for comparing outcomes. RESULTS: Among propensity score-matched patients, aortic clamp time (median 63 vs 52 minutes; P < .0001), cardiopulmonary bypass time (median 88 vs 67 minutes; P < .0001), and postoperative stay (median 7.1 vs 6.9 days; P = .003) were longer for reoperative SAVR than primary isolated SAVR. Hospital mortality after reoperative SAVR decreased from 3.4% in 1985 to 1.3% in 2011, similar to that of primary isolated SAVR. Occurrence of stroke, deep sternal wound infection, and new renal dialysis was similar. Blood transfusion (67% vs 36%; P < .0001) and reoperations for bleeding/tamponade (6.4% vs 3.1%; P = .009) were more common after reoperative SAVR. Survival at 1, 5, 10, and 20 years was 94%, 82%, 64%, and 33% after reoperative SAVR and 95%, 86%, 72%, and 46% after elective primary isolated SAVR. CONCLUSIONS: Risk of mortality and morbidity after reoperative SAVR has declined and is now similar to that of primary isolated SAVR. Decisions regarding prosthesis choice and SAVR versus transcatheter aortic valve replacement should be made in the context of lifelong disease management rather than avoidance of reoperation.

Aortic valve reimplantation in patients with connective tissue disorders: Are the leaflets durable?

OBJECTIVE: The durability of reimplanted myxomatous aortic valves in root replacements for patients with connective tissue disorders (CTD) is unclear; therefore, we sought to evaluate the long-term resilience of these repairs. METHODS: From January 1980 to January 2020, 214 patients with CTD and 645 without CTD underwent primary, elective aortic valve reimplantation operations at Cleveland Clinic. The CTD cohort included 164 (77%) with Marfan, 23 (11%) with Loeys-Dietz, and 7 (3.3%) with Ehlers-Danlos CTD. We accounted for differing patient characteristics between the groups by propensity score matching to compare outcomes, yielding 96 matched pairs. Longitudinal echocardiographic measures were compared using nonlinear mixed effects models. RESULTS: In the CTD cohort, there were no operative mortalities (30-day or in-hospital), 1 (0.47%) stroke, and 1 (0.47%) early in-hospital reoperation for valve dysfunction. Ten-year prevalence of no aortic regurgitation was 86%, mild 11%, and moderate 3%. Ten-year freedom from reoperation was 97%. In propensity matched cohorts, there were no significant differences in in-hospital outcomes, longitudinal aortic regurgitation and mean gradient, risk of reoperation on the aortic valve, or risk of late death. CONCLUSIONS: Aortic valve reimplantation is a durable operation in patients with CTD and root aneurysms. These patients do not experience early degeneration of their reimplanted aortic valves.

Aortic Valve Reconstruction With Autologous Pericardium Versus a Bioprosthesis: The Ozaki Procedure in Perspective.

Background We assessed the Ozaki procedure, aortic valve reconstruction using autologous pericardium, with respect to its learning curve, hemodynamic performance, and durability compared with a stented bioprosthesis. Methods and Results From January 2007 to January 2016, 776 patients underwent an Ozaki procedure at Toho University Ohashi Medical Center. Learning curves, aortic regurgitation (AR), and peak gradient, assessed by serial echocardiograms, valve rereplacement, and survival were investigated. Valve performance and durability were compared with 627 1:1 propensity-matched patients receiving stented bovine pericardial valves implanted from 1982 to 2011 at Cleveland Clinic. Learning curves were observed for aortic clamp and cardiopulmonary bypass times, AR prevalence, and early mortality. Decreased aortic clamp time was observed over the first 300 cases. New surgeons performing parts of the procedure after case 400 resulted in a slight increase in aortic clamp and cardiopulmonary bypass times. Among matched patients, the Ozaki cohort had more AR than the PERIMOUNT cohort (severe AR at 1 and 6 years, 0.58% and 3.6% versus 0.45% and 1.0%, respectively; P[trend]=0.006), although with a steep learning curve. Peak gradient showed the opposite trend: 14 and 17 mm Hg for Ozaki and 24 and 28 mm Hg for PERIMOUNT at these times (P[trend]<0.001). Freedom from rereplacement was similar (P=0.491). Survival of the Ozaki cohort was 85% at 6 years. Conclusions Patients undergoing the Ozaki procedure had lower gradients but more recurrent AR than those receiving PERIMOUNT bioprostheses. Although recurrent AR is concerning, results confirm low risk and good midterm performance of the Ozaki procedure, supporting its continued use.

Characterization of Favorable Right Ventricular Dimensions for Optimal Reverse Remodeling Following Pulmonary Valve Replacement.

We sought to couple current cardiac magnetic resonance (CMR) thresholds of right ventricular (RV) size and function with longitudinal trajectories of RV recovery, after pulmonary valve replacement (PVR). We aimed to identify optimal timing of PVR and couple CMR-based metrics with contemporaneous echocardiographic metrics. From June 2002 to January 2019, 174 patients with severe pulmonary regurgitation and peak RV outflow tract gradient <30 mm Hg underwent PVR at Cleveland Clinic. Mean age was 35 ± 16 years and 60 (34%) had concomitant tricuspid valve surgery. RV end diastolic area index (RVEDAi) and function metrics were measured by offline image review on preoperative and 794 postoperative echocardiograms. Contemporaneous RV end diastolic volume index (RVEDVi) was assessed on CMR and correlated to RVEDAi. Multiphase nonlinear mixed-effects models were used to analyze the longitudinal change in RV size and function after PVR. RVEDAi was correlated with RVEDVi (P < 0.0001, r = 0.59). RVEDAi decreased slowly over 10 years following PVR. An inflection point at 24 cm2/m2 was noted at 1 year post-PVR and was associated with failure of RV reverse remodeling and RVEDVi ≥150 mL/m2. Compared to patients with preoperative RVEDVi ≥150 mL/m2, patients with RVEDVi <150 mL/m2 had accelerated recovery of longitudinal trajectories of RV size and function metrics on echocardiograms. Reverse remodeling of RV following PVR is an ongoing process. Current accepted threshold values for PVR are associated with greatest RV recovery, suggesting that earlier PVR is warranted. Echocardiography can potentially be utilized in lieu of CMR for surveillance and interventional triage.

Survival and repair durability in patients undergoing concomitant aortic valve reimplantation and mitral valve repair.

Objective: The study objective was to determine repair durability and survival in patients with and without connective tissue disorders undergoing concomitant aortic valve reimplantation and mitral valve repair. Methods: From 2002 to 2019, 68 patients underwent concomitant aortic valve reimplantation and mitral valve repair, including 27 patients with Marfan syndrome (39.7%). Follow-up echocardiograms were analyzed using nonlinear multiphase mixed-effects cumulative logistic regression. The regurgitation grade over time was estimated by averaging patient-specific profiles. Survival and freedom from reoperation were estimated by the Kaplan-Meier method. Results: At 7 years, 11% of patients had aortic insufficiency greater than mild (severe in 2 patients). There was no difference in greater than mild aortic insufficiency between patients with or without Marfan syndrome (P = .37). Twenty percent of patients had progressed to mitral regurgitation greater than mild (severe in only 1 patient). The prevalence of recurrent mitral regurgitation was higher in those without Marfan syndrome, with greater than mild regurgitation increasing to 24% by 2 years and remaining constant thereafter (P = .04). Freedom from reoperation on the aortic valve or mitral valve was 83% at 10 years and did not differ between Marfan syndrome groups. There were no cases of perioperative mortality. Survival at 5 and 10 years was 94% and 87%, respectively, without a difference between those with and without Marfan syndrome. Conclusions: Patients can undergo a total repair strategy using combined aortic valve reimplantation and mitral valve repair procedures with a low risk of mortality and complications, with favorable freedom from both residual valve regurgitation and reoperation.

A dynamic Norwood mortality estimation: Characterizing individual, updated, predicted mortality trajectories after the Norwood operation.

Objective: Post-Norwood mortality remains high and unpredictable. Current models for mortality do not incorporate interstage events. We sought to determine the association of time-related interstage events, along with (pre)operative characteristics, with death post-Norwood and subsequently predict individual mortality. Methods: From the Congenital Heart Surgeons' Society Critical Left Heart Obstruction cohort, 360 neonates underwent Norwood operations from 2005 to 2016. Risk of death post-Norwood was modeled using a novel application of parametric hazard analysis, in which baseline and operative characteristics and time-related adverse events, procedures, and repeated weight and arterial oxygen saturation measurements were considered. Individual predicted mortality trajectories that dynamically update (increase or decrease) over time were derived and plotted. Results: After the Norwood, 282 patients (78%) progressed to stage 2 palliation, 60 patients (17%) died, 5 patients (1%) underwent heart transplantation, and 13 patients (4%) were alive without transitioning to another end point. In total, 3052 postoperative events occurred and 963 measures of weight and oxygen saturation were obtained. Risk factors for death included resuscitated cardiac arrest, moderate or greater atrioventricular valve regurgitation, intracranial hemorrhage/stroke, sepsis, lower longitudinal oxygen saturation, readmission, smaller baseline aortic diameter, smaller baseline mitral valve z-score, and lower longitudinal weight. Each patient's predicted mortality trajectory varied as risk factors occurred over time. Groups with qualitatively similar mortality trajectories were noted. Conclusions: Risk of death post-Norwood is dynamic and most frequently associated with time-related postoperative events and measures, rather than baseline characteristics. Dynamic predicted mortality trajectories for individuals and their visualization represent a paradigm shift from population-derived insights to precision medicine at the patient level.

Effect of ascending aorta replacement on the long-term outcomes of bicuspid aortic valve repair.

OBJECTIVE: The study objective was to determine the effect of sinutubular junction stabilization on long-term outcomes of bicuspid aortic valve repair. METHODS: From January 1998 to January 2020, 419 patients underwent bicuspid aortic valve repair with ascending aorta replacement and 421 without (bicuspid aortic valve repair alone). Propensity score matching (97 pairs) was used to compare outcomes. RESULTS: Before matching, prevalence of severe aortic regurgitation at 10 years was 5.4% after bicuspid aortic valve repair + ascending aorta replacement and 10% after bicuspid aortic valve repair alone; aortic valve gradient was 20 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 19 mm Hg after bicuspid aortic valve repair alone. Ten-year freedom from reoperation overall was 79% after bicuspid aortic valve repair + ascending aorta replacement and 75% after bicuspid aortic valve repair alone; freedom from late aortic regurgitation was 93% after bicuspid aortic valve repair + ascending aorta replacement and 92% after bicuspid aortic valve repair alone; and freedom from aortic stenosis was 87% after bicuspid aortic valve repair + ascending aorta replacement and 93% after bicuspid aortic valve repair alone. Ten-year survival was 95% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone. After matching, prevalence of severe aortic regurgitation at 10 years was 11% after bicuspid aortic valve repair + ascending aorta replacement and 9.1% after bicuspid aortic valve repair alone (P = .33); aortic valve gradient was 16 mm Hg after bicuspid aortic valve repair + ascending aorta replacement and 25 mm Hg after bicuspid aortic valve repair alone (P < .0001). Ten-year freedom from reoperation was 85% after bicuspid aortic valve repair + ascending aorta replacement and 72% after bicuspid aortic valve repair alone (P = .08) overall. Ten-year freedom from reoperation for late aortic regurgitation was 88% after bicuspid aortic valve repair + ascending aorta replacement and 86% after bicuspid aortic valve repair alone (P = .65). Freedom from aortic stenosis was 97% after bicuspid aortic valve repair + ascending aorta replacement and 91% after bicuspid aortic valve repair alone (P = .03). Ten-year survival was 96% after bicuspid aortic valve repair + ascending aorta replacement and 96% after bicuspid aortic valve repair alone (P = .16). CONCLUSIONS: Bicuspid aortic valve repair with or without ascending aorta replacement is associated with good short- and long-term outcomes. Bicuspid aortic valve repair + ascending aorta replacement has a minimal effect on long-term repair durability. Sinutubular junction stabilization should not be performed for the sole purpose of long-term repair durability.

Increasing surgeon experience and cumulative institutional experience drive decreasing hospital mortality after reoperative cardiac surgery.

OBJECTIVE: The study objective was to identify the effects of surgeon experience and age, in the context of cumulative institutional experience, on risk-adjusted hospital mortality after cardiac reoperations. METHODS: From 1951 to 2020, 36 surgeons performed 160,338 cardiac operations, including 32,871 reoperations. Hospital death was modeled using a novel tree-bagged, generalized varying-coefficient method with 6 variables reflecting cumulative surgeon and institutional experience up to each cardiac operation: (1) number of total and (2) reoperative cardiac operations performed by a surgeon, (3) cumulative institutional number of total and (4) reoperative cardiac operations, (5) year of surgery, and (6) surgeon age at each operation. These were adjusted for 46 patient characteristics and surgical components. RESULTS: There were 1470 hospital deaths after cardiac reoperations (4.5%). At the institutional level, hospital death decreased exponentially and became less variable, leveling at 1.2% after approximately 14,000 cardiac reoperations. For all surgeons as a group, hospital death decreased rapidly over the first 750 reoperations and then gradually decreased with increasing experience to less than 1% after approximately 4000 reoperations. Surgeon age up to 75 years was associated with ever-decreasing hospital death. CONCLUSIONS: Surgeon age and experience have been implicated in adverse surgical outcomes, particularly after complex cardiac operations, with young surgeons being novices and older surgeons having declining ability. However, at Cleveland Clinic, outcomes of cardiac reoperations improved with increasing primary surgeon experience, without any suggestion to mid-70s of an age cutoff. Patients were protected by the cumulative background of institutional experience that created a culture of safety and teamwork that mitigated adverse events after cardiac surgery.