Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

Characteristics and Prognosis of Patients With Nonvalvular Atrial Fibrillation and Significant Valvular Heart Disease Referred for Electrical Cardioversion.

Valvular atrial fibrillation (AF) is defined as AF in the presence of mitral stenosis or mechanical valve prosthesis. However, there are patients with AF who have significant native valvular heart disease (VHD) others than mitral stenosis that are classified as nonvalvular AF. The characteristics and prognostic implications of these entities have not been extensively studied. Of 1,885 AF patients referred for electrical cardioversion (64 ± 13years, 71% male), 171 (9.1%) had valvular AF (any grade of mitral stenosis or mechanical/biological valve prostheses) and 1,714 patients were identified as nonvalvular AF, of whom 329 (17.5%) had significant left-sided VHD. Patients with nonvalvular AF but with significant left-sided VHD were older, more frequently women and had more co-morbidities compared with the other groups. Furthermore, nonvalvular AF patients with significant left-sided VHD showed the worst left ventricular systolic function and largest left atrial volumes. During a median follow-up of 64 months (interquartile range: 33 to 96 months), 488 patients presented with the combined endpoint of all-cause mortality, heart failure hospitalization, and ischemic stroke. Patients with nonvalvular AF and with significant left-sided VHD had more events of heart failure whereas patients with valvular AF had higher all-cause mortality events. There were no differences in ischemic stroke events. Type of AF was not associated with outcomes after correcting for echocardiographic variables. In conclusion, the frequency of AF patients with significant VHD is relatively high. The consequences of VHD and AF on cardiac structure and function are more important determinants of adverse outcome than the type of AF.

Repair or replacement for severe ischemic mitral regurgitation: A meta-analysis.

BACKGROUND: The best surgical option for severe ischemic mitral regurgitation (IMR) is still controversial. The aim of this study was to perform a meta-analysis to compare the clinical outcomes of mitral valve repair (MVP) with replacement (MVR). METHODS: A literature search was conducted in PubMed, Embase, and Medline using the terms "ischemic mitral regurgitation" and "repair or annuloplasty or reconstruction" and "replacement" in the title/abstract field. The primary outcomes of interest were perioperative mortality and long-term survival. Secondary outcomes were mitral regurgitation (MR) recurrence and reoperation. RESULTS: Of 276 studies, 13 studies met the inclusion and exclusion criteria. A total of 1993 patients were included in these studies, consisting of 1259 (63%) repair cases, and 734 (37%) replacement cases. Perioperative mortality was lower with MVP compared with MVR [OR 0.61; (95% CI, 0.43-0.87; P < .05)]. There was no difference with respect to long-term survival [HR 0.75; (95% CI, 0.52-1.09; P = .14)] and reoperation [OR 0.77; (95% CI, 0.38-1.57; P = .47)]. MVP is associated with a higher recurrence of MR [OR = 4.09; (95% CI, 1.82-9.19; P < .001)]. CONCLUSION: MVP is associated with a lower perioperative mortality but a higher recurrence of MR compared with MVR for severe IMR. No differences were found with respect to long-term survival and reoperation.

Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results.

OBJECTIVE: An aortic annuloplasty ring could be useful for aortic valve repair. This trial evaluated intermediate-term outcomes of internal geometric ring annuloplasty for repair of trileaflet and bicuspid aortic insufficiency associated with ascending aortic and/or aortic root aneurysms. METHODS: Under regulatory supervision, 47 patients with aortic insufficiency and ascending aortic (n = 22) and/or aortic root (n = 25) aneurysms were managed with aortic valve repair and aneurysm resection. Valve repair was performed using trileaflet (n = 40) or bicuspid (n = 7) internal geometric rings, together with leaflet reconstruction. Ascending aortic and/or remodeling root replacements were accomplished with Dacron grafts 5 to 7 mm larger than the rings. An Echo Core Lab provided independent echocardiographic assessments, and changes over time were evaluated by Friedman tests. RESULTS: Mean ± SD age was 60 ± 14 years, 57% (27/47) were male, 15% (7/47) had bicuspid valves, 87% (41/47) had moderate-to-severe aortic insufficiency, and 13% (6/47) had mild aortic insufficiency. All patients had annular dilatation, with a mean ± SD of 26.5 ± 2.6 mm before repair, and mean ± SD ring sizes were 21.7 ± 1.7 mm. Follow-up was 42 months (mean = 27 months). No operative mortality or valve-related complications occurred. Two patients died beyond 1 year from nonvalve-related causes. One patient required valve replacement for repair failure. Survival free of complications or valve replacement was 94% at 2 years. Significant reduction in aortic insufficiency and New York Heart Association class were observed (P < 0.0001), and valve gradients remained low. No heart block or direct ring complications occurred. CONCLUSIONS: In preliminary regulatory studies, aortic ring annuloplasty seemed safe and effective during aortic aneurysm surgery. This approach could help standardize aortic valve repair.

Deep circumferential annuloplasty as an adjunct to repair regurgitant bicuspid aortic valves with a dilated annulus.

BACKGROUND: Failure to address the functional aortic annulus during bicuspid aortic valve (BAV) repair has led to early repair failures. The pathology of regurgitant BAV involves annular dilatation, which is more pronounced anteriorly and deep toward the muscular interventricular septum. In this study, we assessed the results of BAV repair using a strategy of deep circumferential annular support involving the septum in patients with a dilated annulus (>26 mm) and moderate to severe aortic regurgitation (AR). METHODS: Between February 1999 and June 2015, 100 patients with regurgitant (≥2+) BAV and a dilated ventriculoaortic junction (VAJ) (≥26 mm) underwent repair with an adjunctive circumferential annuloplasty (reimplantation procedure or ring). External root dissection to accommodate the annuloplasty was carried deep onto the anterior aspect of the interventricular septum. Follow up was complete in 96 patients, with a median follow-up of 31 months and a total of 362 patient-years. Cox regression analysis was used to predict recurrence of AR. RESULTS: The mean VAJ diameter was 30 ± 4 mm. Seventy-nine patients exhibited delayed prolapse of the anterior leaflet (conjoined right and left cusps in Siever type 1 or anterior cusp in Siever type 0), and 93 patients underwent reimplantation. In the entire study group, there were no in-hospital deaths, and only 1 patient had 2+ AR on discharge. There was 1 late noncardiac death. At 8 years, freedom from AR ≥2+ was 96.4% and freedom from reoperation was 96.8%. Higher preoperative AR grade, small graft size, and use of a ring were predictive of recurrent AR. CONCLUSIONS: Regurgitant BAVs with a dilated annulus display anterior cusp prolapse toward the septum. A deep circumferential annuloplasty may help maintain repair durability.

Patient-tailored aortic root repair in adult marfanoid patients: Surgical considerations and outcomes.

OBJECTIVE: The aim of the study was to evaluate the operative and functional results after individual, patient-tailored aortic root repair in marfanoid patients. METHODS: Among 518 patients who underwent operation between 2002 and January 2016, using patient-tailored aortic root repair with isolated sinus replacement, 42 patients fulfilled the original Ghent criteria. None/trivial, mild, moderate, and severe insufficiency grades were present in 5, 16, 10, and 11 patients, respectively. RESULTS: The repair was adjusted to the existing aortic annulus diameter. Replacement of 1, 2, or 3 sinuses of Valsalva was performed in 1, 14, and 27 patients, respectively. Concomitant cusp repair was performed in 17 patients (40.5%), and 10 patients (23.8%) underwent arch repair (total in 3). All patients survived surgery, and the follow-up (mean, 6.1 ± 3.1; range, 0.8-14.2 years) was 100% complete. No patient had a change in the form or size of the aortic neo-root, especially the size of aortic annulus and sinotubular junction during the follow-up time. No and trivial/mild insufficiency were present in 22 and 18 patients, respectively, and 2 patients with recurrent aortic insufficiency caused by cusp pathology underwent aortic valve replacement 43 and 66 months after the primary surgery, respectively. Thus, the estimated survival free from aortic valve/root reoperation for any reason at 5 and 8 years was 96.8% ± 3.2% and 91.4% ± 6.0%, respectively. CONCLUSIONS: Patient-tailored root repair using isolated sinus replacement is an effective and durable method of valve-sparing repair in select marfanoid patients with a satisfactory quality of aortic cusps, which seems to be decisive for long-term valve function.

Rheumatic Heart Disease Severity, Progression and Outcomes: A Multi-State Model.

BACKGROUND: Rheumatic heart disease (RHD) remains a disease of international importance, yet little has been published about disease progression in a contemporary patient cohort. Multi-state models provide a well-established method of estimating rates of transition between disease states, and can be used to evaluate the cost-effectiveness of potential interventions. We aimed to create a multi-state model for RHD progression using serial clinical data from a cohort of Australian patients. METHODS AND RESULTS: The Northern Territory RHD register was used to identify all Indigenous residents diagnosed with RHD between the ages of 5 and 24 years in the time period 1999-2012. Disease severity over time, surgeries, and deaths were evaluated for 591 patients. Of 96 (16.2%) patients with severe RHD at diagnosis, 50% had proceeded to valve surgery by 2 years, and 10% were dead within 6 years. Of those diagnosed with moderate RHD, there was a similar chance of disease regression or progression over time. Patients with mild RHD at diagnosis were the most stable, with 64% remaining mild after 10 years; however, 11.4% progressed to severe RHD and half of these required surgery. CONCLUSIONS: The prognosis of young Indigenous Australians diagnosed with severe RHD is bleak; interventions must focus on earlier detection and treatment if the observed natural history is to be improved. This multi-state model can be used to predict the effect of different interventions on disease progression and the associated costs.

Temporal trends in transcatheter and surgical aortic valve replacement : An analysis of aortic valve replacements in Germany during 2012-2014.

This analysis of the data of the obligatory quality assurance programme AQUA shows the perioperative risk as well as the procedural outcome evaluated by the observed versus expected in-hospital mortality ratio (O/E ratio) of 62,872 patients undergoing isolated surgical (sAVR), transcatheter transvascular (TV-), or transapical (TA-) aortic valve replacement (TAVI) from 2012 to 2014 in Germany. The number of TAVI procedures increased from 9,352 in 2012 to 13,278 in 2014, whereas the number of sAVR remained constant (2012: 9,949; 2014: 9,953). Between 2012 and 2014, the number of TAVI implanted in patients with a logistic EuroScore I (logESI) of ≤10 % (2012: 21 %; 2014: 26 %) as well as with a logESI <20 % (2012: 57 %; 2014: 64 %) increased. In-hospital mortality in TAVI patients decreased from 5.2 % (TV: 5.0 %; TA: 7.4 %) in 2012 to 4.2 % (TV: 3.8 %; TA: 5.5 %) in 2014, whereas it was stable for sAVR patients (2012: 2.8 %; 2014: 2.6 %). The O/E ratio of TAVI patients decreased from 0.91 (TV: 0.79; TA: 1.2) to 0.73 (TV: 0.69; TA: 0.89), whereas this ratio remained constant for sAVR patients (2012: 0.92; 2014: 0.93). In summary, estimated surgical risk, in-hospital mortality, as well as the O/E ratio for patients undergoing TAVI declined constantly during the last 3 years.

The number of valves requiring surgery does not affect early and late survival in redo valvular surgery.

OBJECTIVES: The purpose of this study was to determine whether the number of operated valves affects early and late outcomes in redo valvular surgery. METHODS: We analysed 328 consecutive patients who underwent a total of 431 redo valvular surgeries from January 1990 to December 2010. The mean age was 61.5 ± 13.0 years. The main indication for redo surgery was structural valve deterioration (66.1%). We divided these patients into the redo single valvular surgery group (Group S, n = 175; 231 redo surgeries) and the redo multivalvular surgery group (Group M, n = 153; 201 redo surgeries). The mean follow-up period was 6.4 ± 5.8 years. The follow-up rate for late survival was 98.3%. RESULTS: The hospital mortality rate was 6.5% in Group S and 7.0% in Group M (P = 0.85). Logistic regression analysis revealed that advanced age and New York Heart Association (NYHA) functional class III or IV were statistically significant independent risk factors for hospital mortality. Re-exploration for bleeding was more likely to occur in Group M than in Group S. The 5- and 10-year survival rates were 84.8 ± 3.0 and 70.8 ± 4.6% in Group S and 82.0 ± 3.5 and 70.2 ± 4.9% in Group M, respectively, with no statistical difference. Cox regression analysis revealed that advanced age, a left ventricular ejection fraction rate of <60% and redo surgery beyond the first redo were independent negative predictors of late mortality. NYHA functional class I or II was a statistically significant positive predictor of late survival. CONCLUSIONS: The number of valves requiring redo surgery does not negatively impact early or late survival. Mortality is not different whether one or multiple valves need to be tackled in a redo scenario.

Need of transannular patch in tetralogy of Fallot surgery carries a higher risk of reoperation but has no impact on late survival: results of Fallot repair in Finland.

OBJECTIVES: Our study is a population-based evaluation of the long-term results after surgical repair for tetralogy of Fallot (TOF). All patients operated on in the country since the first procedure were identified via the Finnish research database of paediatric cardiac surgery and the Finnish population register. The follow-up was 99% completed due to comprehensive coverage of the registers. METHODS: The Finnish research database of paediatric cardiac surgery, surgical logs, diagnosis cards and computer files of the hospitals were used for data collection. The Finnish Population Register Center was used to obtain current patient status and dates of death and emigration. RESULTS: A total of 600 patients underwent surgical repair of TOF before the age of 15 years during the 46-year period from 1962 to 2007. The mean follow-up time was 23 ± 12.1 years; 513 (85%) patients were alive and living in Finland, 82 (14%) had died and 5 patients were lost to the follow-up (0.8%). A total of 40 patients (7%) died early (≤30 days) and 42 (7%) died late (>30 days) after the surgical correction. During the last two decades the early mortality rate was 1.5% and no early deaths were observed after the year 2000. A transannular patch (TAP) was used in the reconstruction of the right ventricular outflow tract in 191 (32%) of these patients and had no influence on late mortality but the event-free survival was significantly inferior in these patients. If a primary palliation was performed before the correction, the late survival was significantly inferior when compared with patients without initial palliation. Also reoperation was more common in patients with primary palliation. CONCLUSIONS: The long-term prognosis of surgically corrected TOF patients is good and has improved with each decade since the beginning of TOF surgery in Finland. Primary repair of tetralogy of Fallot predicts a lower mortality rate and longer freedom from reoperation when compared with two-stage repair. Need of a TAP in TOF surgery carries a higher risk of reoperation but has no impact on late survival.

Reconstruction of fibrous skeleton: technique, pitfalls and results.

Destruction of the mitral-aortic (or mitroaortic) intervalvular fibrosa (IVF) by infective endocarditis is a marker of advanced pathology. Patients are at high risk, as they are sicker, have more comorbidities and have more advanced pathology, requiring a difficult operation that includes debriding and reconstructing the IVF. The anatomy and surgical techniques for that reconstruction are presented and discussed. Operative risk is high and remains high for the first year, before becoming equivalent to that of conventional operations for endocarditis. Current outcomes are better than in the past, but there is room for further improvement.

Clinical outcomes after tricuspid valve annuloplasty in addition to mitral valve surgery.

Current guidelines recommend tricuspid valve annuloplasty (TVP) together with mitral valve surgery in cases of tricuspid annulus dilation (≥40 mm) or functional tricuspid valve regurgitation >2/4. Baseline clinical and echocardiographic data of patients undergoing mitral valve surgery in a single tertiary care hospital between 2007 and 2010 were analyzed. Mortality and heart failure hospitalization data were collected and groups with or without TVP were compared. Patients with TVP (n=89) had similar baseline characteristics compared with patients without (n=86), except for lower right ventricular fractional area change and more concomitant aortic valve surgery. Mortality was higher in the TVP group at 30 days (14% vs 5%; P=.04), but the difference was no longer significant at the end of follow-up. More patients were hospitalized for heart failure in the TVP group (31% vs 17%; hazard ratio, 2.1; 95% confidence interval, 1.1-4.0; P=.05). Right ventricular sphericity index was the only preoperative parameter predicting death or heart failure hospitalizations. In conclusion, patients undergoing TVP in addition to mitral valve surgery are at high risk for early death or subsequent heart failure hospitalizations, which might be partly explained by more complex heart disease. The extent of preoperative right ventricular remodeling may be predictive of adverse outcomes.

Natural history of discrete subaortic stenosisin adults: a multicentre study.

AIMS: Discrete subaortic stenosis (DSS) is often diagnosed early in life and known for its sometimes rapid haemodynamic progression in childhood and strong association with aortic regurgitation (AR). However, data about the evolution of DSS in adulthood are scarce. Therefore, we aimed to evaluate the natural history of DSS, and identify risk factors for the progression of DSS, AR, and intervention-free survival. METHODS AND RESULTS: Conservatively managed adult DSS patients were included in this retrospective multicentre cohort study. Mixed-effects and joint models were used to assess the progression of DSS and AR, and intervention-free survival. Longitudinal natural history data were available for 149 patients [age 20 (IQR: 18-34) years, 48% male]. Sixty patients (40.3%) had associated congenital heart defects (CHDs). The median follow-up duration was 6.3 (IQR: 3.0-12.4) years. The baseline peak left ventricular outflow tract (LVOT) gradient was 32.3 ± 17.0 mmHg and increased by 0.8 ± 0.1 mmHg/year. While the baseline LVOT gradient (P = 0.891) or age (P = 0.421) did not influence the progression rate, the presence of associated CHD was associated with faster progression (P = 0.005). Mild AR was common (58%), but did not significantly progress over time (P = 0.701). The median intervention-free survival was 16 years and associated with the baseline LVOT gradient [hazard ratio (HR) = 3.9 (95% CI: 2.0-7.6)], DSS progression [HR = 2.6 (95% CI: 2.0-3.5)], and AR [HR = 6.4 (95% CI 2.6-15.6)]. CONCLUSION: In contrast to children, DSS progresses slowly in adulthood. In particular, patients with associated CHD are at risk for faster progression and should be monitored cautiously. Discrete subaortic stenosis progression is not influenced by the baseline LVOT gradient or age. Mild AR is common, but non-progressive over time.

Results of reparative surgery for tetralogy of Fallot: data from the European Association for Cardio-Thoracic Surgery Congenital Database.

OBJECTIVES: Right ventricular (RV) dysfunction and pulmonary insufficiency (PI) after tetralogy of Fallot (TOF) repair may contribute to early and late morbidity and mortality. RV dysfunction may be related to the ventriculotomy employed in the transventricular repair technique, particularly when it is combined with a transannular patch (TAP). Transatrial/transpulmonary (TA/TP) repair without ventriculotomy has been advocated as a method potentially diminishing such adverse events. However, the prevalence and early as well as the late results of these different surgical approaches in Europe have not been studied. To ascertain 'the current prevalence and associated early mortality' of various surgical approaches for repair of TOF, relevant data in the European Association for Cardio-Thoracic Surgery Congenital Database were analysed. METHODS: The study population was all types of reparative operations (n = 6654) for patients with primary diagnosis of TOF reported between 1999 and 2011. RESULTS: Overall hospital mortality (HM) was 2.58% (172 of 6654). Repair via ventriculotomy with TAP was the most prevalent technique (n = 3827, 57.5%), with HM 3.11%. Repair via ventriculotomy with non-TAP was performed in 1309 patients (19.7%, HM = 1.53%). Repair without ventriculotomy was performed in 1214 patients (18.2%, HM = 1.48%). Logistic regression analysis showed statistically significant association between HM risk and the type of surgery. In particular, ventriculotomy with TAP is associated with increased mortality risk significantly compared with ventriculotomy with non-TAP (crude odds ratio [OR] 2.13 (95% confidence interval [CI]: 1.33-3.63). Similar results were obtained by analysing for operative mortality risk (30-day mortality, OM). Operations that have been performed before 2005 have resulted in increased surgical risk compared with those performed after 2005 (ORs for OM 1.45, 95% CI: 1.03-2.013). CONCLUSIONS: Overall HM for TOF repair is low. TOF repair by means of ventriculotomy with TAP is the most prevalent approach and is associated with higher mortality. Repair with ventriculotomy but no TAP and repair without ventriculotomy are both less prevalent and with lower mortality. Surgical risk appears to be decreasing over time.

The quality of life after cardiac surgery in octogenarians and evaluation of its early and mid-term results.

OBJECTIVE: The aim of this study is to evaluate our early and mid- term results and the qualities of life of the patients aged eighty years or older who underwent heart surgery. METHODS: Eighty- eight patients aged 80 years and older who underwent open-heart surgery at Göztepe Safak Hospital between May 2004 and December 2010 have been included to the study. This study was designed as two-stage: in the first stage, determinants of survival were analyzed retrospectively. In the second stage, the quality of life of survived patients was evaluated by using Short- Form 36 (SF-36), Turkish version in the cross-sectional study. The statistical analysis was performed using Fischer's exact, Pearson Chi-square test, Student t-test, Mann-Whitney U test and logistic regression analysis. RESULTS: In the logistic regression analysis; the left ventricular ejection fraction as <50% (OR: 11.02, 95% CI: 2.6-46.6, p<0.05), application of redo surgery (OR: 8.3, 95% CI: 1.04-66.6, p<0.05), coronary bypass and mitral surgery procedures in the same session (OR: 9.2, 95% CI: 1.6-53.7, p<0.05), left main coronary lesion as >50% (OR: 4.3, 95% CI: 1.1-17.7, p<0.05), preoperative creatinine as >1.8 mg/dl (OR: 14.1, 95% CI: 2.6-76.1, p<0.01), New York Heart Association class III-IV (OR: 4.9, 95% CI: 1.2-20.1, p<0.05), chronic obstructive pulmonary disease (OR: 10.3, 95% CI: 2.5-41.7, p<0.01) were found to be risk factors of hospital mortality. Physical functions, social functions and all sub-scales other than the role limitation depending on the emotional situation were evaluated as general population mean or above. CONCLUSION: We think that with a successful heart surgery in patients aged 80 years and older under appropriate conditions, their life qualities and mean life expectations can return to normal and they can lead a symptomless life.