328Pulmonary valve replacement in England: trends and outcome over the past two decades (original) (raw)
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Medium term follow-up after percutaneous pulmonary valve replacement with the Melody® valve
IJC Heart & Vasculature, 2015
Introduction Data on long term function of the Melody valve are scarce. Patients and methods single institution; percutaneous pulmonary valve implantation (PPVI) from 2006 to 2014. The function of the valved conduit was analyzed by Doppler echocardiography. Annual Chest X-ray after implant and permanent screening for events (eg. Endocarditis). Results 112 Melody valves were implanted in 111 patients; mean age 19.3 years (4.5-81.6). No prestenting of the RVOT was performed (n=4) at first. In the next 107 patients pre-stenting was always performed. In 82 patients 1 pre-stent, 18 patients 2, in 6 patients 3 stents and 1 patient 4 stents were used. The Melody stent was dilated up to 24 mm (n=4), 22 mm (n=72), 20 mm (n=28) and 18 mm (n=6). When stenotic, the Doppler gradient reduced from 67.0 mmHg (SD 13.9) to 18.9 mmHg (SD 10.4) (p<0.001); pulmonary regurgitation (PR) was reduced from median 3.5/4 (range 0-4/4) to none or trivial (p<0.001). There was no significant change in RVOT peak velocity at 5 y (p=0.122)] nor PR (p=0.835)]. Type 1 Stent fractures were observed in 1/4 non-pre-stented patients and in the 5/107 pre-stented (p<0.05). Endocarditis occurred in 8/112 valves; freedom of endocarditis was 85% at 5 years. In 2 patients early surgical replacement was necessary. Six were sterilized with antibiotic treatment; 2 patients required re-stenting and re-PPVI due to residual gradient. Conclusion Adequate pre-stenting of the RVOT before PPVI nearly abolishes or delays stent fracture. Cusp function is well preserved in mid-term follow-up; endocarditis is a significant threat.
Korean Circulation Journal, 2021
Background and Objectives: We reviewed the long-term outcomes after tetralogy of Fallot (TOF) repair with trans-annular incision; and evaluated the effectiveness of pulmonary valve replacement (PVR) on outcomes. Methods: This was a retrospective review of clinical outcomes of 180 of 196 TOF patients who underwent total correction with trans-annular incision from 1991 to 1997 (PVR group: 81; non-PVR group: 99). Results: The median age of the patients was 14.0 months (interquartile range [IQR], 10.7-19.8 months) at TOF repair. Ten in-hospital deaths (5.1%) occurred. During the followup, 81 patients underwent PVR at the median age of 13.5 years (IQR, 11.2-17.1 years). The patients in PVR group showed better outcomes than non-PVR group in overall survival rate (100% in PVR vs. 88.7% in non-PVR, p=0.007), in all adverse events (arrhythmia, neurologic complications, 95.5% in PVR vs. 74.6% in non-PVR, p=0.024) at 20 years. Age at TOF repair younger than 1 year (hazard ratio [HR], 2.265; p=0.01) and previous shunt history (HR, 2.195; p=0.008) were predictive for requiring PVR. During follow-up, 10 late deaths (5 sudden deaths) occurred in the non-PVR group, mainly due to ventricular arrhythmia and right ventricular failure; there was 1 late death (not a sudden death) in the PVR group. Conclusions: Long-term survival after repair of TOF with trans-annular incision were acceptable. However, arrhythmias were frequently observed during 20 years of follow-up. The patient age <1 year at the time of TOF repair and shunt implantation prior to TOF repair were predictive factors for requiring PVR.
Meta-Analysis of Pulmonary Valve Replacement After Operative Repair of Tetralogy of Fallot
The American Journal of Cardiology, 2010
The review concluded that surgical pulmonary valve replacement in patients after tetralogy of Fallot heart repair was associated with low rates of mortality and significant decreases in right ventricular volumes, but no change in other ventricular functions. The lack of quality assessment and the potential variation between included studies mean that caution is warranted when interpreting the authors' conclusions. Authors' objectives To determine the outcomes and effect on right ventricular function of surgical pulmonary valve replacement in patients after repair of tetralogy of Fallot. Searching PubMed was searched from inception to April 2009 for articles published in English. Search terms were reported. Reference lists of selected papers were also searched. Study selection Observational studies of pulmonary valve replacement after repair of tetralogy of Fallot in adult or paediatric patients were eligible for inclusion. Studies of percutaneous pulmonary valve replacement, case reports and review articles were excluded. The relevant outcomes were early and late all-cause mortality, valve complications and deteriorations requiring redopulmonary valve replacement, changes in QRS duration, and changes in right ventricular volume and ejection fractions. Included studies assessed homograft, bioprosthetic valve conduit, and mechanical valve pulmonary valve replacement. Included patients had a mean age that ranged from 12 to 34 (where reported). Two reviewers independently performed study selection and disagreements between them were resolved. Assessment of study quality The authors did not state that they assessed validity. Data extraction Data were extracted on mortality, valve complications and deteriorations requiring redo-pulmonary valve replacement, changes in QRS duration, and changes in right ventricular volume and ejection fractions; these were used to calculate mean differences and odds ratios (ORs), with 95% confidence intervals (CIs). The authors did not state how many reviewers were involved in data extraction. Methods of synthesis A fixed-effects meta-analysis was conducted to calculate pooled overall mean differences and odds ratios with 95% confidence intervals. Data were also pooled separately for adult and paediatric patients. Statistical heterogeneity was assessed using I 2 statistic and Cochran's Q test. Publication bias was assessed with funnel plots. Results of the review Fifteen studies were included in the review (n=736 patients). The study sample size ranged from 16 to 158 patients. Mean length of follow-up ranged 1.3 to 7.8 years (where reported).
Journal of the American College of Cardiology, 2019
BACKGROUND Transcatheter 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. OBJECTIVES The 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. METHODS Patients 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. RESULTS Data 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 ¼ 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. CONCLUSIONS TV 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.
Late Pulmonary Valve Implantation after Repair of Tetralogy of Fallot
Asian Cardiovascular and Thoracic Annals, 2005
Ten cases of elective late pulmonary valve implantation after repair of tetralogy of Fallot were reviewed. The interval after initial repair ranged from 1.5 to 43 years (mean, 20.0 ± 12.3 years). There was no hospital mortality or late death during a mean follow-up of 12.5 months. Preoperatively, 9 patients were in New York Heart Association functional class III–IV; after pulmonary valve implantation, all 10 patients were in class I–II (average improvement, 1.7 classes). Left ventricular ejection fraction improved significantly (from 62.1% ± 4.7% to 70.2% ± 4.9%), as did fractional shortening (from 34.0% ± 5.0% to 40.0% ± 4.2%). Right ventricular diameter decreased significantly (from 32.3 ± 7.5 to 24.4 ± 5.4 mm). QRS duration decreased significantly (155.2 ± 27.1 vs. 140.0 ± 21.2 msec), but there was no significant difference in QT interval (460.9 ± 29.6 vs. 451.9 ± 50.6 msec). Hospital stay was 4–7 days. One patient had preoperative ventricular fibrillation requiring resuscitation...
Circulation. Cardiovascular interventions, 2013
Transcatheter (percutaneous) pulmonary valve (TPV) replacement has emerged as a viable therapy for right ventricular outflow tract conduit dysfunction. Little is known about the incidence, clinical course, and outcome of infective endocarditis (IE) after TPV implant. We reviewed combined data from 3 ongoing prospective multicenter trials to evaluate the experience with IE among patients undergoing TPV replacement using the Melody valve. Any clinical episode reported by investigators as IE with documented positive blood cultures and fever, regardless of TPV involvement, was considered IE. Cases were classified as TPV-related if there was evidence of vegetations on or new dysfunction of the TPV. The 3 trials included 311 patients followed for 687.1 patient-years (median, 2.5 years). Sixteen patients were diagnosed with IE 50 days to 4.7 years after TPV implant (median, 1.3 years), including 6 who met criteria for TPV-related IE: 3 with vegetations, 2 with TPV dysfunction, and 1 with b...
Determinants and Outcomes of Acute Transcatheter Valve-in-Valve Therapy or Embolization
Journal of the American College of Cardiology, 2013
This study investigated the determinants and outcomes of acute insertion of a second transcatheter prosthetic valve (TV) within the first (TV-in-TV) or transcatheter valve embolization (TVE) after transcatheter aortic valve replacement (TAVR). Background TAVR failure can occur with both TV-in-TV and TVE as a consequence of TAVR malpositioning. Only case reports and limited series pertaining to these complications have been reported to date. Methods Patients undergoing TAVR in the PARTNER (Placement of AoRTic TraNscathetER Valve Trial Edwards SAPIEN Transcatheter Heart Valve) randomized trial (cohorts A and B) and accompanying registries were studied. Data were dichotomized for those with and without TV-in-TV or TVE, respectively. Results From a total of 2,554 consecutive patients, 63 (2.47%) underwent TV-in-TV and 26 (1.01%) TVE. The indication for TV-in-TV was significant aortic regurgitation in most patients, often due not only to malpositioning but also to leaflet dysfunction. Despite similar aortic valve function on follow-up echoes, TV-in-TV was an independent predictor of 1-year cardiovascular mortality (hazard ratio [HR]: 1.86, 95% confidence interval [CI]: 1.03 to 3.38, p ¼ 0.041), with a nonsignificant trend toward greater all-cause mortality (HR: 1.43, 95% CI: 0.88 to 2.33, p ¼ 0.15). Technical and anatomical reasons accounted for most cases of TVE. A multivariable analysis found TVE to be an independent predictor of 1-year mortality (HR: 2.68, 95% CI: 1.34 to 5.36, p ¼ 0.0055) but not cardiovascular mortality (HR: 1.30, 95% CI: 0.48 to 3.52, p ¼ 0.60). Conclusions Acute TV-in-TV and TVE are serious sequelae of TAVR, often resulting in multiple valve implants. They carry an excess of mortality and are caused by anatomic and technical factors, which may be avoidable with judicious procedural planning.
Long-Term Outcomes of Tricuspid Valve Replacement in the Current Era
The Annals of Thoracic Surgery, 2005
Background. Regardless of the indication, tricuspid valve replacement (TVR) has historically been associated with high mortality and morbidity. We report the results of our experience in a high-risk patient population with an emphasis on operative mortality, long-term survival, and valve related events according to the type of prosthesis. Methods. Between 1985 and 1999 TVR was performed in 81 patients (isolated n ؍ 25, combined with valve surgery n ؍ 44, combined with CABG or other n ؍ 12). The mean age was 61 years old (range 19-83 years old). Risk factors included New York Heart Association functional class III/IV (n ؍ 73, 90%), reoperation (n ؍ 58, 72%), urgent/emergent indication (n ؍ 62, 76%), and hepatic dysfunction (n ؍ 13, 16%). Mean pulmonary artery pressure was 34 mmHg. Etiology of tricuspid regurgitation was classified as functional (n ؍ 18, 22%) or organic (n ؍ 52, 64%), or failed previous tricuspid valve surgery (n ؍ 11, 14%). Results. Tricuspid valve replacement was performed with either a bioprosthetic (n ؍ 34, 42%) or mechanical valve (n ؍ 47, 58%). The overall operative mortality was 22% (n ؍ 18). Risk factors for mortality included urgent/ emergent status, age greater than 50 years old, functional etiology, and elevated pulmonary artery pressure. Of the 60 survivors, 26 (43%) died during follow up. After univariate analysis, organic etiology was the only predictor of late death (p ؍ 0.01). Kaplan-Meier survival at 2.5, 5, and 10 years was 80%, 60%, and 45% for bioprosthetic, and 84%, 69%, and 59% for mechanical valves, respectively. Conclusions. Patients requiring TVR are typically high-risk with a high-percentage of reoperations, concomitant cardiac procedures, and end-stage functional class. Operative and overall mortality remains high. Heart failure was the predominant cause of early and late deaths, emphasizing importance of timely referral before the development of end-stage cardiac impairment.
Congenital Heart Disease, 2008
Objective. The purpose of this study was to assess the outcome of pulmonary valve replacement (PVR) in adults with moderate/severe pulmonary regurgitation after tetralogy repair, with particular emphasis on patient outcome, durability of valve repair, and improvement in symptomatology. Design/Setting/Patients. The project committee of the International Society of Congenital Heart Disease undertook a retrospective multi-institutional analysis of PVR. Seven centers participated in submitting data on 93 patients >18 years of age who had the operation performed and follow-up obtained. The average age of PVR was 26Ϯ years (median 27 years). Time of follow-up after replacement was 3 years (range 4 days-28 years). Outcomes/Measures/Results. Kaplan-Meier estimates of durability of PVR showed approximately 50% replacement at 11 years. There were two deaths at 6 and 12 months after valve replacement. Right ventricular (RV) size estimated by echocardiography from pre-to postoperative studies decreased in 81% (P < 0.001 testing for equal proportions), but RV systolic function increased in only 36% (P = 0.09). Ability index improved in 59% (P < 0.001) and clinical heart failure status improved in 57% with this problem before PVR. PVR did not improve arrhythmia status in a small group of patients. Conclusions. PVR is associated with low mortality, decrease in RV size and improvement in ability index, and uncertain effects on RV systolic function. Average valve durability was approximately 11 years. Criteria for PVR that will preserve RV function are not clearly identified, and management of these patients remains a difficult enterprise.