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1.

Objective

Transcatheter aortic valve replacement is established therapy for high-risk and inoperable patients with severe aortic stenosis, but questions remain regarding long-term durability. Valve design influences durability. Increased leaflet stresses in surgical bioprostheses have been correlated with degeneration; however, transcatheter valve leaflet stresses are unknown. From 2007 to 2014, a majority of US patients received first-generation balloon-expandable transcatheter valves. Our goal was to determine stent and leaflet stresses in this valve design using finite element analyses.

Methods

A 26-mm Sapien Transcatheter Heart Valve (Edwards Lifesciences, Inc, Irvine, Calif) underwent high-resolution microcomputed tomography scanning to develop precise 3-dimensional geometry of the leaflets, the stent, and the polyethylene terephthalate elements. The stent was modeled using 3-dimensional elements and the leaflets were modeled using shell elements. Stent material properties were based on stainless steel, whereas those for leaflets were obtained from surgical bioprostheses. Noncylindrical Sapien valve geometry was also simulated. Pressure loading to 80 mm Hg and 120 mm Hg was performed using ABAQUS finite element software (Dassault Systèmes, Waltham, Mass).

Results

At 80 mm Hg, maximum principal stresses on Sapien leaflets were 1.31 megaspascals (MPa). Peak leaflet stress was observed at commissural tips where leaflets connected to the stent. Maximum principal stresses for the stent were 188.91 MPa and located at stent tips where leaflet commissures were attached. Noncylindrical geometry increased peak principal leaflet stresses by 16%.

Conclusions

Using exact geometry from high-resolution scans, the 26-mm Sapien Transcatheter Heart Valve showed that peak stresses for both stent and leaflets were present at commissural tips where leaflets were attached. These regions would be prone to leaflet degeneration. Understanding stresses in first-generation transcatheter valves allows comparison to future designs for relative durability.  相似文献   

2.

Objective

The goal of this study is to evaluate how sinus flow patterns after transcatheter aortic valve replacement in realistic representative patient roots vary. Sinus flow can affect transcatheter aortic valve operation and likely leaflet thrombosis occurrence due to stasis and poor washout. How the interaction between transcatheter aortic valve and representative patient aortic roots affects sinus hemodynamics is important to establish for future individualization of transcatheter aortic valve replacement therapy.

Methods

Two representative patient aortic roots were selected, segmented and 3-dimensional printed followed by deployment of Medtronic CoreValve (Medtronic Inc, Irvine, Calif) and Edwards SAPIEN (Edwards Lifesciences, Irvine Calif) transcatheter aortic valves. Sinus hemodynamics were assessed in vitro using high spatio-temporal resolution particle-image-velocimetry. Detailed sinus vortex tracking, shear stress probability density functions, and sinus washout were evaluated and assessed as a function of valve type and representative patient morphology as independent case studies.

Results

Peak velocity in the sinus with SAPIEN valve was approximately 3 times higher than with CoreValve for both models (0.30 ± 0.02 m/s and 0.34 ± 0.041 m/s vs 0.13 ± 0.01 m/s and 0.10 ± 0.02 m/s) (P < .01). Between representative patient models, vorticity magnitudes were significantly different (75 ± 1.1 s?1, 77 ± 3.2 s?1, 109 ± 2.3 s?1, and 250 ± 4.1 s?1) (P < .01) regardless of valve type. Sinus blood washout characteristic as a function of cardiac cycles was strongly both patient related and valve specific. Fluid dynamics favored shear stresses and washout characteristics due to a smaller sinus and sinotubular junction, further amplified by the SAPIEN valve.

Conclusions

Sinus flow dynamics are highly sensitive to aortic root characteristics and transcatheter aortic valve aortic root interaction. Differences in sinus-flow washout and stasis regions between representative patient models may be reflected in different risks of leaflet thrombosis or valve degeneration.  相似文献   

3.

Objectives

This study aimed at evaluating the efficacy and safety of the transaortic approach for the transcatheter aortic valve implantation procedure using balloon-expandable and self-expanding devices.

Methods

From January 2012 to December 2016, the transaortic-transcatheter aortic valve implantation procedure was performed in 206 consecutive patients at the Rangueil University Hospital. All procedures were performed by a multidisciplinary heart team. The ascending aorta (27%) or innominate artery (73%) was exposed through a J-type manubriotomy. Events were adjudicated according to Valve Academic Research Consortium-2 criteria.

Results

Mean age and logistic European System for Cardiac Risk Evaluation II were 83.9 ± 6.7 years and 16.8% ± 10.8%, respectively. Balloon-expandable and self-expanding valves were implanted in 59.7% and 40.3% of patients, respectively. Device success rate was 98.1%. Thirty-day overall mortality, cardiovascular mortality, cerebrovascular event, myocardial infarction, and permanent pacemaker implantation rates were 5.3%, 4.4%, 1.5%, 1.0%, and 9.7%, respectively (1-year rates: 15.5%, 9.2%, 3.9%, 3.4%, and 10.2%, respectively). Life-threatening bleeding and major vascular complications (7.3% and 3.9%, respectively) were not related to the central access site in approximately half of the cases. Multivariable Cox regression analysis identified preoperative renal failure as an independent predictor of overall mortality (odds ratio, 2.82; 95% confidence interval, 1.73-4.59; P < .0001). At the 1-year follow-up, most patients had experienced improved functional status and 98.4% of them were free of moderate to severe paravalvular leak.

Conclusions

In a higher-risk subgroup within the patient population receiving transcatheter aortic valve implantation, transaortic-transcatheter aortic valve implantation was successfully performed in 98.1% of cases, with high functional improvement and low rates of mortality and adverse events, especially neurologic complications.  相似文献   

4.

Objective

Long-term outcomes of prosthetic aortic valve/root replacement in patients aged 30 years or younger are not well understood. We report our single institutional experience in this young cohort.

Methods

From 1998 to 2016, 99 patients (age range, 16-30 years) underwent aortic valve replacement (n = 57), aortic valve replacement and supracoronary ascending aorta replacement (n = 6), or aortic root replacement (n = 36). A prospectively maintained aortic valve database was retrospectively reviewed to complete longitudinal functional and clinical data. Total follow-up was 493 patient years.

Results

Surgical indications included primary stenosis/insufficiency (52% [n = 51]), Marfan syndrome (10% [n = 10]), and endocarditis (33.3% [n = 33]). Fifty-eight patients (59%) underwent mechanical valve replacement, with 41 patients (41%) receiving a biologic/bioprosthetic valve. Twenty-five patients underwent aortic valve reoperation after index procedure with following indications: prosthesis–patient mismatch 1.0% (n = 1), prosthetic valve degeneration/dysfunction 10% (n = 10), connective tissue 2% (n = 2), and endocarditis 12% (n = 12). Mortality (30-day/in-hospital) and stroke rate were 3.0% (n = 3) and 1% (n = 1), respectively. One-, 5-, and 10-year actuarial freedom from aortic valve reoperation by valve type was 89.1%, 84.6%, and 69.4% for the Mechanical Valve group and 89.6%, 70.9%, and 57.6% for the Biologic/Bioprosthetic Valve group, respectively (log rank P = .279). Replacement valve size ≤21 mm was a significant risk factor for reoperation, and was associated with progression of mean aortic valve transvalvular gradients over follow-up. Valve type had no effect.

Conclusions

The choice of mechanical versus biologic/bioprosthetic valve does not affect freedom from reoperation or survival rates in this young cohort during mid- to long-term follow-up. Smaller aortic valve replacement size (≤21 mm) is a significant risk factor for reoperation and progression of mean aortic valve gradients.  相似文献   

5.

Objective

Native aortic valve calcium and transcatheter aortic valve oversize have been reported to predict pacemaker implantation after transcatheter aortic valve insertion. We reviewed our experience to better understand the association.

Methods

We retrospectively reviewed the records of 300 patients with no prior permanent pacemaker implantation who underwent transcatheter aortic valve insertion from November 2008 to February 2015. Valve oversize was calculated using area. The end point of the study was 30-day postoperative pacemaker implantation.

Results

Patient data included age of 81.1 ± 8.4 years, female sex in 135 patients (45%), atrial fibrillation in 74 patients (24.7%), Society of Thoracic Surgeons predicted risk of mortality of 7.6% (interquartile range [IQR], 5.3-10.6), aortic valve calcium score of 2568 (IQR, 1775-3526) Agatston units, and annulus area of 471 ± 82 mm2. Balloon-expandable valves were inserted in 244 patients (81.3%). Transcatheter aortic valve oversize was 12.8% (IQR, 3.9-23.3). Pacemaker implantation was performed in 59 patients (19.7%). Aortic valve calcium score (adjusted P = .275) and transcatheter valve oversize (adjusted P = .833) were not independent risk factors for pacemaker implantation when controlling for preoperative right bundle branch block (adjusted odds ratio, 3.49; 95% confidence interval, 1.61-8.55; P = .002), implantation of self-expanding valve (adjusted odds ratio, 4.09; 95% confidence interval, 1.53-10.96; P = .005), left bundle branch block (adjusted P = .331), previous percutaneous coronary intervention (adjusted P = .053), or valve surgery (adjusted P = .111), and PR interval (adjusted P = .350).

Conclusions

Right bundle branch block and implantation of a self-expanding prosthesis were predictive of pacemaker implantation, but not native aortic valve score or transcatheter valve oversize.  相似文献   

6.

Objectives

Structural valve deterioration (SVD) remains a major bioprosthesis-related complication, as recently described for the Mitroflow valve (models LX and 12A) (LivaNova, London, United Kingdom). The real incidence of the SVD risk remains unclear, often due to methodologic pitfalls by systematically using the Kaplan-Meier estimator and/or the Cox model. In this report, we propose for the first time a precise statistical modeling of this issue.

Methods

Five hundred sixty-one patients who underwent aortic valve replacement with the aortic Mitroflow valve between 2002 and 2007 were included. We used an illness–death model for interval-censored data. Median follow-up was 6.6 years; 103 cases of SVD were diagnosed.

Results

The 4-year and 7-year SVD cumulative incidences after the first anniversary of surgery were 15.2% (95% confidence interval, 11.9-19.1) and 31.0% (95% confidence interval, 25.8-37.2), respectively. Female gender, dyslipidemia, chronic obstructive pulmonary disease, and severe patient-prosthesis mismatch were significant risk factors of SVD. The occurrence of SVD was associated with a 2-fold increase in the risk of death.

Conclusions

Appropriate statistical models should be used to avoid underestimating the SVD complication associated with worse long-term survival.  相似文献   

7.

Objective

Aortic valve repair is currently in transition from surgical improvisation to a reproducible operation and an option for many patients with aortic regurgitation. Our research efforts at improving reproducibility include development of methods for intraoperatively testing and visualizing the valve in its diastolic state.

Methods

We developed a device that can be intraoperatively secured in the transected aorta allowing the aortic root to be pressurized and the closed valve to be inspected endoscopically. Our device includes a chamber that can be pressurized with crystalloid solution and ports for introduction of an endoscope and measuring gauges. We show use of the device in explanted porcine hearts to visualize the aortic valve and to measure leaflet coaptation height in normal valves and in valves that have undergone valve repair procedures.

Results

The procedure of introducing and securing the device in the aorta, pressurizing the valve, and endoscopically visualizing the closed valve is done in less than 1 minute. The device easily and reversibly attaches to the aortic root and allows direct inspection of the aortic valve under conditions that mimic diastole. It enables the surgeon to intraoperatively study the valve immediately before repair to determine mechanisms of incompetence and immediately after the repair to assess competence. We also show its use in measuring valve leaflet coaptation height in the diastolic state.

Conclusions

This device enables more relevant prerepair valve assessment and also enables a test of postrepair valve competence under physiological pressures.  相似文献   

8.

Objective

To assess risk factors for paravalvular leak (PVL) after transcatheter aortic valve implantation in a large single-center cohort, including measurement of aortic valve calcification using a reproducible method.

Methods

We retrospectively analyzed preoperative contrast-enhanced multidetector computed tomography scans of patients who underwent transcatheter aortic valve implantation in our center between 2009 and 2016. Calcium volume was calculated for each aortic cusp in the aortic valve, left ventricular outflow tract, and device landing zone.

Results

Overall, 539 patients were included in the study who had experience with 4 prothesis types (SapienXT [Edwards Lifesciences, Irvine, Calif] [n = 192], Sapien3 [Edwards Lifesciences] [n = 206], CoreValve EvolutR [Medtronic, Minneapolis, Minn] [n = 44], and Acurate [Symetis, Ecublens, Switzerland] [n = 97]). Median calcium volume in the device landing zone was 757 mm3, with no significant differences among the 4 prosthesis groups. None of the patients had severe PVL. The overall incidence of mild-to-moderate PVL was 15.8% (95% confidence interval [CI], 12.8%-19.1%). On multivariate logistic regression, device landing zone calcification (P = .00006; odds ratio for an increase of 100 mm3, 1.08; 95% CI, 1.04-1.13) and use of the CoreValve (P = .0028; odds ratio, 4.1; 95% CI, 1.6-10 with SapienXT as reference) prosthesis were found to be associated with mild or greater PVL. In contrast, degree of oversizing (P = .002; odds ratio, 0.97; 95% CI, 0.95-0.99), and use of Sapien3 (P = .00005; odds ratio, 0.23; 95% CI, 0.11-0.47 with SapienXT as reference) were associated with a lower incidence of mild or greater PVL.

Conclusions

Aortic calcification volume in the device landing zone is associated with residual PVL after transcatheter aortic valve implantation. When taking calcification into account, the balloon-expandable prosthesis Sapien3 seems to be associated with a lower incidence of PVL.  相似文献   

9.

Objective

Coronary obstruction remains a challenging complication of transcatheter aortic valve replacement; however, a new self-expanding transapical prosthesis may reduce this risk. The purpose of this study was to evaluate the early 1-year outcomes of patients with low coronary heights who received the Acurate TA bioprosthesis (Symetis, Ecublens, Switzerland).

Methods

Between May 2014 and April 2015, 30 consecutive patients (aged 85 ± 6 years, 63% were female, Society of Thoracic Surgeons score 8.4 ± 6.0) with severe, symptomatic aortic stenosis underwent transcatheter aortic valve replacement with the Acurate TA bioprosthesis. Relevant patient characteristics included reoperation in 47% (n = 14), peripheral vascular disease in 43% (n = 13), and porcelain aorta in 30% (n = 9). The mean left and right coronary heights were 10.8 ± 1.5 mm and 16.4 ± 4.1 mm, respectively, with a sinus of Valsalva : annular ratio of 1.3 ± 0.8.

Results

All 30 device implants were successful. The 30-day in-hospital mortality was 3.3% (n = 1), and no patients had coronary obstruction or stroke. One patient (3.3%) had apical rupture requiring cardiopulmonary bypass for repair, 1 patient (3.3%) had a localized femoral artery dissection, and 1 patient (3.7%) required a new pacemaker. There were no other complications. Mean and peak transaortic valve gradients decreased from 59 ± 17 and 84 ± 31 mm Hg to 14 ± 7 and 28 ± 12 mm Hg, respectively (P < .0005). No patients had more than mild paravalvular aortic insufficiency. At 30 days, there were no further complications and 96.7% (n = 29) were in New York Heart Association class I/II. Survival at 30 days and 1 year was 97% and 89%, respectively.

Conclusions

The Symetis Acurate TA device demonstrates high procedural success and excellent acute and 1-year patient outcomes. The device allows safe implantation in patients at higher risk for coronary artery obstruction.  相似文献   

10.

Objective

To evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve.

Methods

In a multicenter, prospective, nonrandomized, follow-up study, 710 patients underwent surgical implantation of a pericardial stented aortic prosthesis (Trifecta valve; St Jude Medical, St. Paul, Minn). The valve is constructed from bovine pericardium mounted externally onto a titanium stent. Subjects were followed on an annual basis over 6 years.

Results

Operations were performed from 2007 to 2009, and mean age was 72.4 ± 9.3 years; 471 of 710 (66.3%) were men. Preoperatively, 361 of 710 (50.8%) of patients were in New York Heart Association class III or IV, and at 6 years postoperatively, 92 of 96 (95.8%) were New York Heart Association class I or II. Six years postoperatively, average mean gradient across all valve sizes was 11.0 mm Hg, and the average effective orifice area index was 0.80 cm2/m2. The proportion of patients without moderate-to-severe valvular regurgitation at 6 years was 95.2% (80/84). Six years postoperatively, freedom from valve-related mortality, nonstructural dysfunction, and paravalvular leak were 98.3%, 98.6%, and 98.9%, respectively, and freedom from reoperation due to structural valve deterioration was 97.3% (95% confidence limits, 98.6-94.7).

Conclusion

These midterm results demonstrate that the Trifecta valve is a safe and effective valve substitute with excellent hemodynamic performance and durability that is maintained through the 6-year follow-up period.  相似文献   

11.

Objective

Ideal heart valve solutions aim to provide thrombosis-free durability. A scaffold-based polycarbonate urethane urea tissue-engineered heart valve designed to mimic native valve microstructure and function was used. This study examined the acute in vivo function of a stented tissue-engineered heart valve in a porcine model.

Methods

Trileaflet valves were fabricated by electrospinning polycarbonate urethane urea using double component fiber deposition. The tissue-engineered heart valve was mounted on an AZ31 magnesium alloy biodegradable stent frame. Five 80-kg Yorkshire pigs underwent open tissue-engineered heart valve implantation on cardiopulmonary bypass in the pulmonary position. Tissue-engineered heart valve function was echocardiographically evaluated immediately postimplant and at planned study end points at 1, 4, 8, and 12 hours. Explanted valves underwent biaxial mechanical testing and scanning electron microscopy for ultrastructural analysis and thrombosis detection.

Results

All 5 animals underwent successful valve implantation. All were weaned from cardiopulmonary bypass, closed, and recovered until harvest study end point except 1 animal that was found to have congenital tricuspid valve dysplasia and that was euthanized postimplant. All 5 cases revealed postcardiopulmonary bypass normal leaflet function, no regurgitation, and an average peak velocity of 2 m/s, unchanged at end point. All tissue-engineered heart valve leaflets retained microstructural architecture with no platelet activation or thrombosis by scanning electron microscopy. There was microscopic evidence of fibrin deposition on 2 of 5 stent frames, not on the tissue-engineered heart valve. Biaxial stress examination revealed retained postimplant mechanics of tissue-engineered heart valve fibers without functional or ultrastructural degradation.

Conclusions

A biodegradable elastomeric heart valve scaffold for in situ tissue-engineered leaflet replacement is acutely functional and devoid of leaflet microthrombosis.  相似文献   

12.

Objective

Transcatheter aortic valve replacement (TAVR) procedures were introduced in 2011. Initially, procedures were limited to patients who were not surgical candidates, but subsequently high-risk surgical candidates were considered for TAVR. The influence on aortic valve surgery in California is unknown.

Methods

The California Office of Statewide Health Planning and Development hospitalized patient discharge database was queried for the years 2009 through 2014. isolated surgical aortic valve and aortic valve/coronary artery bypass graft (SAVR) and TAVR procedures were identified by International Classification of Diseases-9th revision clinical modification procedure codes. Seven TAVR programs were introduced in 2011, 12 in 2012, 3 in 2013, and 6 in 2014. SAVR procedure volumes were compared from the 2 years before institution with SAVR volumes during the year(s) after institution of the TAVR program in these 28 hospitals.

Results

Overall, surgical volumes increased during the first, second, and third years after implementation of TAVR procedures. Among 7 hospitals with 4-year programs, surgical volumes increased to a maximum of 15.5% during the third year, then began to decrease. The hospital performing the largest number of TAVR procedures showed a marked decrease in SAVR volume by the fourth year, suggesting a shift of SAVR candidates to TAVR. Among all hospitals with 4-year programs, TAVR exceeded SAVR procedures by the fourth year. In California overall, SAVR increased during 2011 through 2013, due primarily to increasing volume of isolated SAVR procedures. Statewide, isolated SAVR increased from a yearly average of 3111 procedures during 2009-2010 to 3592 (+15.5%) in 2013, then decreased slightly in 2014. SAVR plus coronary artery bypass graft procedures decreased during the same time period.

Conclusions

After implementation of TAVR, hospital SAVR volumes increased moderately, then began to decrease by the fourth year, when TAVR volume exceeded SAVR. Surgical candidates may be identified during evaluation for TAVR, resulting in increased SAVR volume. Increasing SAVR volume may also be related to improved patient and provider awareness of aortic valve disease.  相似文献   

13.

Objectives

There are little recent data on the outcomes of mechanical aortic valve replacement (AVR) in children and young adults with congenital aortic valve disease. We sought to review the survival and associated thromboembolic or bleeding complications after mechanical AVR at a single center.

Methods

Data were retrospectively collected for 121 patients undergoing prosthetic AVR from 2000 to 2014. Kaplan-Meier estimates and Cox proportional hazards were employed.

Results

Median age at AVR was 16 years (interquartile range, 12-22.8 years). The valves implanted were the St Jude valve (St Jude Medical Inc, St Paul, Minn) in 79 patients (62%), the On-X valve (On-X Life Technologies Inc, Austin, Tex) in 45 patients (35%), and CarboMedics (Sorin SpA, Milan, Italy) in 3 patients (2.4%). Median valve size was 23 mm (range, 21-25 mm). There were 5 early deaths (3.9%). Median follow-up was 5 years (range, 1.6-9.2 years; 600 patient-years). There were 14 deaths during follow-up. Survival was 90.6% ± 2.8% at 1 year, 85.4% ± 3.7% at 5 years, and 81.5% ± 4.5% at 10 years. Freedom from aortic valve reoperation was 98% ± 1.4% at 1 and 5 years, 91.5% ± 3.9% at 7 years, and 78.4% ± 6.9% at 10 years and at latest follow-up. Univariable analysis identified younger age, lower weight, and use of a 16-mm CarboMedics valve as predictors of reoperation. Valve sizes of 16 or 17 mm have a significantly higher risk of reoperation compared with larger valves (log-rank test, P < .001). At multivariable analysis, only younger age was a significant independent predictor of reoperation (hazard ratio, 0.84; 95% confidence interval, 0.71-0.99; P = .038). All patients were treated with warfarin to a goal international normalized ratio of 2.0 to 3.0. Four patients (3.1%; 0.66% per patient-year) had thromboembolic complications, and 5 patients (3.9%; 0.83% per patient-year) had bleeding events during follow-up.

Conclusions

Mechanical AVR in patients with congenital heart disease has excellent short- and midterm outcomes. Younger age was an independent predictor of reoperation.  相似文献   

14.

Background

The objective was to evaluate the long-term outcomes of the St Jude Medical (Saint Paul, Minn) mechanical valve prosthesis implantation.

Methods

Since 1979, every patient receiving this prosthesis has been followed annually.

Results

From January 1979 to December 2014, 1023 patients were accrued. Patients' ages ranged from 18 to 85 years. Aortic valve replacement was performed in 584 patients, and mitral valve replacement was performed in 439 patients. Follow-up was 95% complete. Operative mortality was 3% (17/584, aortic valve replacement) and 4% (18/439, mitral valve replacement). In patients undergoing aortic valve replacement, late actuarial survival was 62% ± 2%, 32% ± 2%, and 14% ± 3% at 10, 20, and 30 years, respectively. Thirty-year freedom from reoperation, thromboembolism, valve thrombosis, bleeding, and endocarditis was 92% ± 2%, 79% ± 3%, 96% ± 1%, 56% ± 5%, and 92% ± 2%, respectively. In patients undergoing mitral valve replacement, late actuarial survival was 64% ± 3%, 28% ± 3%, and 14% ± 3% at 10, 20, and 30 years, respectively. Thirty-year freedom from reoperation, thromboembolism, valve thrombosis, bleeding, and endocarditis was 85% ± 5%, 55% ± 6%, 99% ± 1%, 57% ± 6%, and 95% ± 2%, respectively. The incidence of bleeding was 2.5% and 2.0% per patient-year for aortic valve replacement and mitral valve replacement, respectively. The incidence of thromboembolism was 1.6% and 2.9% per patient-year for aortic valve replacement and mitral valve replacement, respectively.

Conclusions

Annual follow-up of all of our patients receiving a St Jude Medical mechanical valves prosthesis has allowed better identification valve-related issues and events. After 3 decades of observation with close follow-up, the St Jude Medical mechanical valve continues to be a reliable prosthesis.  相似文献   

15.

Objective

The study objective was to examine the long-term results of the Ross procedure in a cohort of patients followed prospectively for more than 2 decades.

Methods

From 1990 to 2004, 212 consecutive patients with a median age (interquartile range) of 34 years (28-41) underwent the Ross procedure; 82% had congenital aortic valve disease. The technique of aortic root replacement was used in one half of the patients. Patients have been followed prospectively for a median (interquartile range) of 18.0 (14.6-21.2) years. Valve function was assessed by echocardiography.

Results

Cumulative mortality at 20 years was 10.8% (95% confidence interval, 6.5-17.8). Thirty patients required Ross-related reoperations and 3 for coronary artery disease. The cumulative probability of Ross-related reoperations at 20 years was 16.8% (95% confidence interval, 11.3-24.5), on the pulmonary autograft was 11.5% (95% confidence interval, 7.2-18.0), and on the pulmonary homograft was 8.2% (4.6-14.7). The implantation technique was not associated with the cumulative incidence of reoperations on the pulmonary autograft. The development of moderate or severe aortic insufficiency and pulmonary homograft dysfunction increased with time. At 20 years, the probability of aortic insufficiency was 13% (95% confidence interval, 8.0-20.3) and of pulmonary homograft dysfunction was 19.7% (95% confidence interval, 13.9-27.2). Preoperative aortic insufficiency was associated with increased odds of postoperative aortic insufficiency.

Conclusions

The long-term results of the Ross procedure are excellent regardless of the implantation technique, but there is a progressive deterioration of function of both semilunar valves.  相似文献   

16.

Background

Transcatheter aortic valve-in-valve implantation (TAVI-ViV) is an evolving treatment strategy for degenerated surgical aortic valve bioprostheses (SAVBs). However, there is some concern regarding coronary obstruction, especially after TAVI-ViV in calcified SAVBs with externally mounted leaflets. We investigated in vitro coronary flow and hydrodynamics after TAVI-ViV using 2 modern SAVBs with externally and internally mounted leaflets.

Methods

Aortic root models including known risk factors for coronary obstruction served for the implantation of SAVBs with either externally mounted leaflets (St Jude Trifecta, size 25) or internally mounted leaflets (Edwards Perimount Magna Ease, size 25). Left and right coronary flow, as well as hydrodynamic parameters, were measured before and after TAVI-ViV with an Edwards Sapien XT transcatheter heart valve, size 23. After the first experimental run, the SAVB leaflets were artificially “calcified,” and the measurements were repeated.

Results

In both models, noncalcified and calcified, there was no significant reduction in coronary flow with either the Trifecta or the Perimount Magna Ease SAVB. After TAVI-ViV, in the noncalcified model, the mean pressure gradient was increased (Trifecta, P = .0001; Perimount Magna Ease, P = .006) and the geometric orifice area was decreased (P < .001 for both), whereas in the calcified model, the mean pressure gradient was decreased (P < .001 for both) and the geometric orifice area was increased (P < .001 for both).

Conclusions

In our specific model, in noncalcified as well as calcified conditions, TAVI-ViV is feasible with either SAVB (Trifecta or Perimount Magna Ease) without an increased risk of coronary obstruction. Nevertheless, before clinical application of these results, thorough preoperative assessment, considering the different limitations of this model, is mandatory.  相似文献   

17.

Objectives

Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study.

Methods

The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline.

Results

There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year.

Conclusions

Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation.  相似文献   

18.

Objective

Although the Ross procedure provides excellent long-term survival and a high quality of life, its use has been limited to relatively few centers. In this study, we evaluated long-term Ross procedure results in adults to assess the predictors of pulmonary autograft durability.

Methods

Between 1998 and 2015, 793 consecutive adult patients underwent the Ross procedure. The total root replacement technique was used in all patients.

Results

The early mortality rate was 2.9%. The mean follow-up duration was 6.5 ± 3.2 years, and the 10-year survival rate was 90.4%. Longitudinal mixed-effects ordinal regression identified a combination of bicuspid aortic valve and aortic insufficiency (odds ratio, 2.19; P < .001) as predictors for progression of autograft valve insufficiency at follow-up. The cumulative incidence of autograft reoperations at 10 years was 8.6%. Competing risk regression identified bicuspid aortic valve insufficiency as the independent predictor of autograft reoperation (subdistribution hazard ratio, 2.16; P = .030). Moreover, patients with bicuspid aortic valve and aortic insufficiency had greater increases in annulus (P < .001), sinus (P < .001), and ascending aorta (P < .001) diameters over time.

Conclusions

For patients undergoing the Ross procedure, a combination of bicuspid aortic valves and aortic insufficiency is the main risk factor for late autograft dilatation and dysfunction.  相似文献   

19.

Objective

Explore causes and timing of death from the CoreValve US Pivotal High-Risk Trial.

Methods

An independent clinical events committee adjudicated causes of death, followed by post hoc hierarchical classification. Baseline characteristics, early outcomes, and causes of death were evaluated for 3 time periods (selected based on threshold of surgical 30-day mortality and on the differences in the continuous hazard between the 2 groups): early (0-30 days), recovery (31-120 days), and late (121-365 days).

Results

Differences in the rate of death were evident only during the recovery period (31-120 days), whereas 15 patients undergoing transcatheter aortic valve replacement (TAVR) (4.0%) and 27 surgical aortic valve replacement (SAVR) patients (7.9%) died (P = .025). This mortality difference was largely driven by higher rates of technical failure, surgical complications, and lack of recovery following surgery. From 0 to 30 days, the causes of death were more technical failures in the TAVR group and lack of recovery in the SAVR group. Mortality in the late period (121-365 days) in both arms was most commonly ascribed to other circumstances, comprising death from medical complications from comorbid disease.

Conclusions

Mortality at 1 year in the CoreValve US Pivotal High-Risk Trial favored TAVR over SAVR. The major contributor was that more SAVR patients died during the recovery period (31-121 days), likely affected by the overall influence of physical stress associated with surgery. Similar rates of technical failure and complications were observed between the 2 groups. This suggests that early TAVR results can improve with technical refinements and that high-risk surgical patients will benefit from reducing complications.  相似文献   

20.

Objective

Although transcatheter aortic valve implantation has been shown to be noninferior to surgical aortic valve replacement in patients with severe aortic stenosis at intermediate surgical risk, the cost-effectiveness of this strategy in this population is unknown. Our objective was to conduct a cost-utility analysis comparing transcatheter aortic valve implantation with surgical aortic valve replacement in the population with intermediate risk severe aortic stenosis.

Methods

A fully probabilistic Markov model with 30-day cycles was constructed from the Canadian third-party payer's perspective to estimate the difference in cost and effectiveness (measured as quality-adjusted life years) of transcatheter aortic valve implantation versus surgical aortic valve replacement for intermediate-risk patients over a lifetime time horizon, discounted at 1.5% per annum. Clinical trial data from The Placement of Aortic Transcatheter Valve 2 informed the efficacy inputs. Costs (adjusted to 2016 Canadian dollars) were obtained from the Canadian Institute of Health Information and the Ontario Schedule of Benefits. Incremental cost-effectiveness ratios were calculated.

Results

In the base-case analysis, total lifetime costs for transcatheter aortic valve implantation were $10,548 higher than surgical aortic valve replacement but added 0.23 quality-adjusted life years, for an incremental cost-effectiveness ratio of $46,083/quality-adjusted life-years gained. Deterministic 1-way analyses showed that the incremental cost-effectiveness ratio was sensitive to rates of complications and cost of the transcatheter aortic valve implantation prosthesis. There was moderate-to-high parameter uncertainty; transcatheter aortic valve implantation was the preferred option in only 52.7% and 55.4% of the simulations at a $50,000 and $100,000 per quality-adjusted life years willingness-to-pay thresholds, respectively.

Conclusions

On the basis of current evidence, transcatheter aortic valve implantation may be cost-effective for the treatment of severe aortic stenosis in patients with intermediate surgical risk. There remains moderate-to-high uncertainty surrounding the base-case incremental cost-effectiveness ratio.  相似文献   

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