Independent risk factors for an increased incidence of thromboembolism after lung transplantation.

BACKGROUND: Thromboembolism (TE) after lung transplantation (LTX) is associated with increased morbidity and mortality. The aim of this study is to analyze the incidence and outcome of venous and arterial thromboembolic complications and to identify independent risk factors. PATIENTS AND METHODS: We retrospectively analyzed the medical records of 221 patients who underwent LTX at our institution between 2002 and 2021. Statistical analysis was performed using SPSS and GraphPad software. RESULTS: 74 LTX recipients (33%) developed TE. The 30-days incidence and 12-months incidence were 12% and 23%, respectively. Nearly half of the patients (48%) developed pulmonary embolism, 10% ischemic stroke. Arterial hypertension (p = 0.006), a body mass index (BMI) > 30 (p = 0.006) and diabetes mellitus (p = 0.041) were independent predictors for TE. Moreover, a BMI of > 25 at the time of transplantation was associated with an increased risk for TE (43% vs. 32%, p = 0.035). At the time of LTX, 65% of the patients were older than 55 years. An age > 55 years also correlated with the incidence of TE (p = 0.037) and these patients had reduced overall post-transplant survival when the event occurred within the first postoperative year (59% vs. 72%, p = 0.028). CONCLUSIONS: The incidence of TE after LTX is high, especially in lung transplant recipients with a BMI > 25 and an age > 55 years as well as cardiovascular risk factors closely associated with the metabolic syndrome. As these patients comprise a growing recipient fraction, intensified research should focus on the risks and benefits of regular screening or a prolonged TE prophylaxis in these patients. Trial registration number DKRS: 00021501.

Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study.

PURPOSE: Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) is currently the major threat for immunocompromised individuals. The course of COVID-19 in lung transplant recipients in the Omicron era remains unknown. The aim of the study was to assess outcome and associated factors in lung transplant recipients in a German-wide multicenter approach. METHODS: All affected individuals from January 1st to March 20th, 2022 from 8 German centers during the Omicron wave were collected. Baseline characteristics and antiviral measures were associated with outcome. RESULTS: Of 218 patients with PCR-proven SARS-CoV-2 infection 166 patients (76%) received any early (< 7 days) antiviral therapy median 2 (interquartile range 1-4) days after symptom onset. Most patients received sotrovimab (57%), followed by remdesivir (21%) and molnupiravir (21%). An early combination therapy was applied in 45 patients (21%). Thirty-four patients (16%) developed a severe or critical disease severity according to the WHO scale. In total, 14 patients (6.4%) died subsequently associated with COVID-19. Neither vaccination and antibody status, nor applied treatments were associated with outcome. Only age and glomerular filtration rate < 30 ml/min/1.73m2 were independent risk factors for a severe or critical COVID-19. CONCLUSION: COVID-19 due to Omicron remains an important threat for lung transplant recipients. In particular, elderly patients and patients with impaired kidney function are at risk for worse outcome. Prophylaxis and therapy in highly immunocompromised individuals need further improvement.

Five-year Outcome of an Early Everolimus-based Quadruple Immunosuppression in Lung Transplant Recipients: Follow-up of the 4EVERLUNG Study.

BACKGROUND: Everolimus-based quadruple low calcineurin inhibitor (CNI) maintenance immunosuppression has been shown to be effective in preserving short-term renal function without compromising efficacy or safety after lung transplantation; however, long-term benefit remains unknown. METHODS: An investigator-initiated 5-y follow-up analysis of the 4EVERLUNG study (NCT01404325), comparing everolimus-based quadruple low CNI with standard triple regimen, was performed. Patients who remained on the randomized drug regimen until the end of the 5-y observation were analyzed as the per protocol (PP) population. Patients in whom the assigned regimen was switched were analyzed as the intention-to-treat (ITT) population. RESULTS: In total, 123 patients (95%) from the core study were analyzed. During the observation period in 11 patients (19%) of the standard triple regimen and in 30 patients (46%) of the quadruple low CNI regimen, the assigned immunosuppressive regimen was switched ( P = 0.002). Estimated glomerular filtration rate at 5-y follow-up did not differ between the groups in both the ITT (56 [48-73] versus 58 [48-69] mL/min; P =0.951) and PP (59 [50-73] versus 59 [48-69] mL/min; P = 0.946) populations. Thromboembolic events occurred more frequently in the quadruple low CNI regimen (ITT: 11% versus 24%, P = 0.048; PP: 11% versus 22%, P = 0.162). There was a trend for a higher chronic lung allograft dysfunction-free survival for the quadruple low CNI regimen in the PP population ( P = 0.082). No difference in the graft survival was found. CONCLUSIONS: Initiation of an early everolimus-based quadruple low CNI regimen may have no long-term benefit on renal function. The immunosuppressive efficacy and safety profile seems comparable with the standard triple regimen.

Surveillance Bronchoscopy for the Care of Lung Transplant Recipients: A Retrospective Single Center Analysis.

INTRODUCTION: Lung transplantation is often the only treatment for end-stage lung disease. Following lung transplantation, infections and transplant rejections are major obstacles to short- and long-term success. Therefore, close monitoring for these complications is required after lung transplantation. The role of prescheduled surveillance bronchoscopies after lung transplantation is controversial. Thus, we aimed to retrospectively analyze the therapeutic implications of surveillance bronchoscopies in 110 consecutive lung transplant recipients. MATERIALS AND METHODS: Results of 400 prescheduled surveillance bronchoscopies of 110 consecutive lung transplant recipients were analyzed. Positive results (pathologic histology, microbiology, or virology) were further investigated for their effect on clinical decision making. Additionally, cellular composition of bronchoalveolar lavage (BAL) was analyzed. RESULTS: Two hundred five surveillance bronchoscopies showed pathologic findings. In 81 cases clinical treatment was changed based on the results. That is, 20% of all prescheduled bronchoscopies directly influenced clinical decision making. Furthermore, analyses of BAL indicate that increased alveolar eosinophils are associated with an increased risk of transplant rejection. CONCLUSIONS: Prescheduled surveillance bronchoscopies identify clinically unsuspected but therapeutically relevant pathologic findings in approximately 20% of cases. BAL cell composition may confer additional information, especially in cases when biopsy is not possible.

Kinetics of Torque Teno Virus-DNA Plasma Load Predict Rejection in Lung Transplant Recipients.

BACKGROUND: Lung transplantation is the only therapeutic option in end-stage lung diseases; however, survival after transplantation is limited by acute and chronic rejection or infectious events being results of inappropriate immunosuppression. Torque Teno Viruses (TTVs) are ubiquitous DNA viruses in humans but not found to be causative for any disease. However, some reports suggest that TTV-DNA levels reflect the grade of immunosuppression with higher levels being found in more immunosuppressed individuals. METHODS: We investigated the TTV-DNA levels in 34 lung transplant recipients within their first year after transplantation by quantitative real-time polymerase chain reaction. Clinical data were extracted from charts. RESULTS: In accordance with previous results TTV-DNA levels increase after lung transplantation reaching a steady state after 3 months. The TTV-DNA levels were not correlated with immunosuppressive trough levels and a selective increase was not observed with other DNA viruses. In steady state TTV-DNA levels were significantly higher in patients with infectious complications compared to the group of patients without. Additionally, TTV-DNA levels decreased significantly before biopsy-proven rejection. Sensitivity of a 10-fold decrease in TTV-DNA levels for a subsequent rejection episode was 0.74 with a specificity of 0.99. CONCLUSIONS: In summary, TTV-DNA might be used as an additional tool to monitor immunosuppression in lung transplant recipients. Higher TTV-DNA levels reflect more intense immunosuppression, whereas the TTV-DNA kinetic (ie, decrease of TTV-DNA levels) indicate rejection.

Abdominal pain, unconsciousness, and skin rash after lung transplantation.

Long-term success of lung transplantation is limited by allograft dysfunction and frequent infections. Varicella zoster virus infection (VZV) is one of the most common opportunistic infections among solid organ transplantation recipients. However the occurrence of visceral involvement or disseminated disease, as seen after bone marrow transplantation, is rare. We report a case of a 59-year-old woman who underwent double-lung transplantation with a fatal visceral and disseminated varicella zoster virus infection.

Quality of Life and Anxiety in Younger Patients after Biological versus Mechanical Aortic Valve Replacement.

Background Since biological valve recipients are likely to need a redo procedure in the future for valve deterioration, we hypothesized patients might be more fearful about the progression of their disease than patients after aortic valve replacement (AVR) with a mechanical valve. The aim of this study is to compare the quality of life (QOL) and anxiety in patients who have undergone biological versus mechanical AVR. Method A total of 56 patients after mechanical AVR (mean age: 64.4 ± 8.17 years) and 66 patients after biological AVR (mean age: 64.8 ± 11.05 years) received three questionnaires 5.66 (± 2.68) years after surgery, including: The short form-36 (SF-36) to assess QOL, the fear of progression questionnaire (FOP), and the cardiac anxiety questionnaire (CAQ) to assess general anxiety, anxiety related to cardiac symptoms, and anxiety about progression of heart disease and valve and anticoagulation-specific questions. Results No significant differences were found for all categories of the SF-36. The FOP showed significantly favorable values for the biological AVR group. The CAQ showed a tendency in the subscale "avoidance" (i.e., avoidance of pulse increase) and "attention" towards more favorable values for the biological AVR group. Conclusions In contrast to our hypothesis, patients after mechanical AVR show significantly higher anxiety values for the FOP, and a tendency toward higher values for "avoidance" (i.e., avoidance of pulse increase). Partnership concerns, especially in terms of sexuality can be explained by factors that are recognizable for the partner, such as valve sound. These data provide evidence that factors that are continuously present after mechanical AVR, such as valve sound or anticoagulation might affect wellbeing stronger than the certainty of reoperation in the future after biological AVR. We conclude that implantation of a biological prosthesis can be justified in younger patients with regards to QOL.

Exercise training improves exercise capacity and quality of life after transcatheter aortic valve implantation: A randomized pilot trial.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is increasingly applied for aortic stenosis in elderly patients with impaired mobility and reduced quality of life. These patients may particularly benefit from postinterventional exercise programs, but no randomized study has evaluated the safety and efficacy of exercise in this population. METHODS: In a prospective pilot study, 30 patients after TAVI (mean age, 81±6 years, 44% female, 83±34 days postintervention) were randomly allocated 1:1 to a training group (TG) performing 8 weeks of supervised combined endurance and resistance exercise or to usual care. The formal primary efficacy end point was between-group difference in change in peak oxygen uptake assessed by cardiopulmonary exercise testing; secondary end points included muscular strength, 6-minute walk distance, and quality of life (Kansas City Cardiomyopathy Questionnaire and Medical Outcomes Study 12-Item Short-Form Health Survey questionnaires). Safety was assessed by documenting training-related adverse events, prosthesis, and renal function. RESULTS: Significant changes in favor of TG were observed for peak oxygen uptake (group difference, 3.7 mL/min per kg [95% CI, 1.1-6.3; P=.007]), muscular strength (bench press, 6 kg [95% CI, 3-10; P=.002]; rowing, 7 kg [95% CI, 3-11; P<.001]; pulldown, 9 kg [95% CI, 4-14; P=.001]; shoulder press, 5 kg [95% CI, 1-8; P=.008]; leg press, 17 kg [95% CI 6-28; P=.005]), components of quality of life (Kansas City Cardiomyopathy Questionnaire physical limitation, 19.2 [95% CI, 4.1-34.2; P=.015]; symptom burden, 12.3 [95% CI, 0.5-24.0; P=.041]; clinical summary, 12.4 [3.4-21.4; P=.009]), but not for other questionnaire subscales and 6-minute walk distance (15 m [95% CI, -23 to 53; P=.428]). Three dropouts unrelated to exercise occurred (TG=2; usual care,=1); prosthesis and renal function were not affected by the exercise intervention. CONCLUSIONS: In patients after TAVI, exercise training appears safe and highly effective with respect to improvements in exercise capacity, muscular strength, and quality of life. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT01935297.

Early hemodynamic performance of the BioValsalva valved conduit after aortic root replacement.

BACKGROUND AND AIM OF THE STUDY: The study aim was to examine the hemodynamic performance of the BioValsalva porcine aortic valve conduit in the aortic root position. METHODS: Between February 2007 and April 2012, a total of 223 patients underwent aortic root replacement at the authors' institution. The BioValsalva valved conduit was implanted in 131 patients, and 86 of these patients (mean age 64.7 +/- 9.7 years) consented to participate in the present study. The parameters assessed to evaluate prosthetic valve function included mean pressure gradient (MPG) as measured by transthoracic Doppler echocardiography, and the effective orifice area (EOA) by means of the continuity equation. Hemodynamic data were obtained from all 86 patients within 10 days and six months postoperatively. RESULTS: The mean aortic cross-clamp time was 103 +/- 30 min. Concomitant procedures were performed in 50 patients (56.5%). Four patients developed valve dysfunction due to endocarditis, and underwent a reoperation without the need to perform a redo Bentall. The early MPG across the implanted valve was 12 +/- 4.6 mmHg (range: 4-24.8 mmHg), and the early mean EOA was 1.81 +/- 0.6 cm2 (range: 0.9-3.2 cm2). After six months the MPG was 11.6 +/- 4.6 mmHg (range: 2.2-25.5 mmHg) and the EOA was 1.69 +/- 0.43 cm2 (range: 0.8-2.6 cm2). CONCLUSION: Based on its special design with a stentless valve, which is not incorporated into the proximal suture line, the BioValsalva conduit has an advantage over intraoperatively prepared conduits in cases of reoperation. Besides simplified intraoperative handling, the BioValsalva conduit exhibits good systolic hemodynamic performance with large EOAs.

Aortic root replacement: comparison of clinical outcome between different surgical techniques.

OBJECTIVES: To examine the influence of different surgical procedures on clinical outcome in patients undergoing aortic root replacement for ascending aorta aneurysm (AAA) with or without concomitant aortic valve regurgitation (AR). METHODS: Between 2000 and 2011, a total of 370 patients (mean age 52 ± 17 years) underwent aortic root replacement. Patients were retrospectively assigned to three groups according to the surgical procedures: valve-sparing root replacement (VSRR) (Group A; n = 178), Bentall procedure with a biological conduit (Group B; n = 91) and with a mechanical conduit (Group C; n = 101). All patients were studied with clinical assessment and echocardiography during a mean follow-up time of 4.3 years. RESULTS: Estimated 5-year survival probability rates for Groups A, B and C were 95.2 ± 1.8, 80.9 ± 4.4 and 79.3 ± 4.5%, respectively (P < 0.01; log-rank). Estimated 5-year survival probability rates for patients who had undergone elective operations for Groups A, B and C were 96.1 ± 1.8, 88.9 ± 4.4 and 82.3 ± 4.9%, respectively (P = 0.02; log-rank). Actuarial overall 5-year freedom from valve-related reoperations was 94.3 ± 1.9%, without being significantly different between groups (P = 0.13; log-rank). Estimated 5-year probability rates for freedom from major bleeding events for Groups A, B and C were 99.3 ± 0.7, 100 and 93.0 ± 3.4%, respectively (P = 0.03; log-rank). Actuarial overall 5-year freedom from thromboembolism and endocarditis were 93.6 ± 0.2% (P = 0.53; log-rank) and 96.1 ± 1.5% (P = 0.46; log-rank), respectively, without significant differences between groups. CONCLUSIONS: The data from the present study support the VSRR strategy in patients undergoing aortic root replacement. Furthermore, if Bentall operation is unavoidable, biological valved conduit should be preferred in order to avoid late bleeding complications.

Incidence and impact of prosthesis-patient mismatch after transcatheter aortic valve implantation.

BACKGROUND AND AIM OF THE STUDY: The study aim was to investigate the incidence of patient-prosthesis mismatch (PPM) with new catheter valves, and its influence on the patients' clinical state. At present, few echocardiographic data are available on the incidence and impact of PPM with the CoreValve and Sapien prostheses for transcatheter aortic valve implantation (TAVI). METHODS: The reliability of effective orifice area (EOA) measurements was assured by awaiting an interval of six months after TAVI. Of 256 survivors after TAVI, 149 complete echocardiographic data sets were available for the assessment of the indexed EOA (iEOA). In total, 106 CoreValve prostheses and 43 Sapien prostheses were implanted in this high-risk cohort (mean age 81 +/- 6 years, mean logistic EuroSCORE 20 +/- 13%). RESULTS: The overall incidence of PPM (iEOA < 0.85 cm2/m2) was 61%. Patients with a larger body surface area were more likely to develop PPM (p = 0.001), while the prosthesis type, native annulus diameter, preoperative EOA, gender and prosthesis size had no influence. The mean aortic gradient was significantly higher in patients with PPM. A reduction in the left ventricular end-diastolic diameter was seen in all patients, without significant differences between groups. There were no differences in postoperative NYHA class or self-assessed health state between patients with or without PPM. CONCLUSION: PPM was common after TAVI in the presented cohort, presumably because the native calcium masses narrow the outflow area available for blood flow. As expected for low gradients, there was no impairment of left ventricular dimension regression or clinical state of the patients, even if severe PPM was present. Based on the presented data, it is assumed that PPM might be less relevant in TAVI patients.

Safety and efficacy of the subclavian access route for TAVI in cases of missing transfemoral access.

OBJECTIVE: We retrospectively analysed our experience with the subclavian access transcatheter aortic valve implantation (TAVI) with the self-expandable CoreValve prosthesis and compared the results with transfemorally treated patients. BACKGROUND: For TAVI, a subclavian access is alternatively used when the femoral arteries are diseased or very small. METHODS: Between June 2007 and February 2011, 341 patients underwent CoreValve implantation in the German Heart Center, Munich through either transfemoral (n = 301) or subclavian (n = 40) approach. The subclavian approach was chosen where transfemoral approach was not possible. RESULTS: There was no difference in baseline characteristics between the groups. There were no significant differences between groups for parameters potentially related to improved valve positioning (contrast medium, fluoroscopy time, implantation of a second valve, post-implantation balloon dilatation, valve dislocation, pacemaker implantation, aortic regurgitation), while the procedure duration was longer (105 ± 40 vs. 82 ± 33 min, p = 0.001). With the Kaplan-Meier estimate, survival was not different among groups. Strokes, myocardial ischaemia, and access vessel complications occurred in 2.5, 0, and 7.5 % (subclavian group) vs. 4.3, 2.0, 10.6 % (transfemoral group), ns. CONCLUSIONS: Our results demonstrate the safety of the subclavian access for TAVI and comparability with the transfemoral approach. With longer duration of the procedure and no significant advantages in clinical outcome, the subclavian access will have an indication for selected patients, while transfemoral TAVI should be considered first choice.

The evolution and prognostic value of N-terminal brain natriuretic peptide in predicting 1-year mortality in patients following transcatheter aortic valve implantation.

AIMS: N-terminal pro-brain natriuretic peptide (NT-proBNP) has been found to correlate with the severity of aortic valve stenosis and to provide prognostic information in aortic stenosis patients undergoing surgical aortic valve replacement. There is a paucity of data describing the association between clinical outcomes after TAVI and NT-proBNP levels. We investigated the evolution and prognostic value of NT-proBNP levels after TAVI. METHOD AND RESULTS: We prospectively collected data on the baseline characteristics, NT-proBNP levels (baseline, post-treatment and discharge) and adverse clinical outcomes of patients undergoing TAVI from 2007 to 2010. Using a univariable and multivariable Cox regression model, pre- and postimplantation NT-proBNP tertile levels were correlated to 30-day and 1-year mortality. A total of 373 patients underwent TAVI with either the Medtronic CoreValve or Edwards SAPIEN prosthesis. The cumulative 30-day and 1-year mortality was 7.3% and 18%, respectively. Rehospitalization for heart failure was observed in 0.8% at 30 days and 7.8% at 1 year. The tertile baseline NT-proBNP levels were identified as ≤1570 ng/L, 1571 to 4690 ng/L and ≥4691 ng/L. In the univariable analysis, baseline (HR, 1.01; 95% CI, 1.001-1.02; P=.02) and post-treatment NT-proBNP (HR 1.02; 95% CI, 1.002-1.04; P=.04) were predictors for 1-year mortality. In the multivariable analysis, however, only baseline NT-proBNP and atrial fibrillation were identified as predictors for the 1-year mortality (HR, 1.02; 95% CI, 1.01-1.05; P=.006 and HR, 3.4; 95% CI, 1.25-9.5; P=.017, respectively). CONCLUSIONS: NT-proBNP and atrial fibrillation were predictors for 1-year mortality, offer independent prognostic information, and identify patients being at increased risk for mortality. Thus, NT-proBNP reveals more incremental value for patient selection and should be included in the risk stratification of patients undergoing TAVI.

Tricuspid valve repair: is ring annuloplasty superior?

OBJECTIVES: Tricuspid regurgitation (TR) secondary to left heart disease is the most common aetiology of tricuspid valve (TV) insufficiency. Valve annuloplasty is the primary treatment for TV insufficiency. Several studies have shown the superiority of annuloplasty with a prosthetic ring over other repair techniques. We reviewed our experience with different surgical techniques for the treatment of acquired TV disease focusing on long-term survival and incidence of reoperation. METHODS: A retrospective analysis of 717 consecutive patients who underwent TV surgery between 1975 and 2009 with either a ring annuloplasty [Group R: N = 433 (60%)] or a De Vega suture annuloplasty [Group NR: no ring; N = 255 (36%)]. Twenty-nine (4%) patients underwent other types of TV repair. A ring annuloplasty was performed predominantly in the late study period of 2000-09. TV aetiology was functional in 67% (479/717) of the patients. Ninety-one percent of the patients (n = 649) underwent concomitant coronary artery bypass grafting and/or mitral/aortic valve surgery. RESULTS: Patients who received a ring annuloplasty were older (67 ± 13 vs 60 ± 13 years; P < 0.001). Overall 30-day mortality was 13.8% (n = 95) [Group R: n = 55 (12.7%) and Group NR: n = 40 (15.7%)]. Ten-year actuarial survival after TV repair with either the De Vega suture or ring annuloplasty was 39 ± 3 and 46 ± 7%, respectively (P = 0.01). Twenty-eight (4%) patients required a TV reoperation after 5.9 ± 5.1 years. Freedom from TV reoperation 10 years after repair with a De Vega annuloplasty was 87.9 ± 3% compared with 98.4 ± 1% after the ring annuloplasty (P = 0.034). CONCLUSIONS: Patients who require TV surgery either as an isolated or a combined procedure constitute a high-risk group. The long-term survival is poor. Tricuspid valve repair with a ring annuloplasty is associated with improved survival and a lower reoperation rate than that with a suture annuloplasty.

Transcatheter aortic valve implantation in patients with concomitant mitral and tricuspid regurgitation.

BACKGROUND: The impact of atrioventricular valve regurgitation in patients who undergo transcatheter aortic valve implantation (TAVI) is not known. We examined the clinical outcome after TAVI in patients with moderate or more severe concomitant mitral or tricuspid regurgitation (TR). METHODS: Two hundred sixty-eight consecutive patients who underwent TAVI at our institution since July 2007 were enrolled in this study. Patients had preoperative echocardiographic assessment of aortic stenosis and concomitant valve disease. At 6 months and 1 year, survival, New York Heart Association (NYHA) functional status, self-assessed state of health, and severity of mitral regurgitation (MR) and tricuspid regurgitation (TR) were assessed. RESULTS: Preoperatively, 22.4% of patients (60/268) had moderate or more severe MR, 20.1% (54/268) had moderate or more severe TR, and 9.3% (25/268) had moderate or more severe MR and TR. With moderate or more severe TR, 1 year all-cause mortality was significantly higher compared with that of mild or less severe TR (33.9% and 20.9%, respectively; log rank p = 0.028). With moderate or more severe MR, 1-year all-cause mortality was 30.2% compared with 21.2% in mild or less severe MR (log rank p = 0.068). Neither moderate or more severe MR nor TR emerged as an independent risk factor. At 6 months, heart failure symptoms were significantly reduced regardless of the extent of atrioventricular valve regurgitation. Sixty-seven percent of patients with moderate or more severe MR and 50% of patients with moderate or more severe TR had an improvement of valve regurgitation. CONCLUSIONS: Atrioventricular valve regurgitation is present in a subgroup of patients undergoing TAVI whose survival is impaired. The majority of surviving patients exhibit the clinical benefits of TAVI with amelioration of heart failure symptoms and a decrease in severity of atrioventricular valve regurgitation. At present, moderate or more severe atrioventricular valve regurgitation cannot be considered a contraindication for TAVI.

Beyond the short-term: clinical outcome and valve performance 2 years after transcatheter aortic valve implantation in 227 patients.

OBJECTIVE: Although the procedural feasibility of transcatheter aortic valve implantation has been shown by multiple groups, longer-term data are rare. We report on 2-year follow-up clinical and echocardiographic results after transcatheter aortic valve implantation in 227 patients. METHODS: Patients' mean age was 81 ± 7 years, 59% were female, mean European System for Cardiac Operative Risk Evaluation was 21% ± 14%, mean Society of Thoracic Surgeons score was 7% ± 5%, and access routes were transfemoral (n = 164), transapical (n = 54), axillary (n = 5), or transaortic (n = 4). A CoreValve (Medtronic Inc, Minneapolis, Minn) prosthesis was implanted in 174 patients, and a SAPIEN prosthesis (Edwards Lifesciences, Irvine, Calif) was implanted in 53 patients. Clinical and echocardiographic investigations were performed at 6 months, 1 year, and 2 years. RESULTS: Survival was 88.5% at 30 days, 75.9% at 6 months, 74.5% at 1 year, and 64.4% at 2 years. Patients improved significantly in New York Heart Association class after 6 months (from 3.2 ± 0.5 to 1.7 ± 0.7, P < .001) and up to 2 years (1.9 ± 0.7). Cumulative incidences of myocardial infarction, stroke, and life-threatening or major bleeding were 2.7%, 6.2%, and 16.2% at 2 years, respectively. The postprocedural mean transprosthetic gradient was 12 ± 4 mm Hg for all valves and did not change up to 2 years, and the effective orifice area was 1.5 ± 0.4 cm² with no change over 2 years of follow-up. Moderate or severe prosthetic regurgitation was present in 8% of patients at 2 years. In 6% of patients, the paravalvular or valvular regurgitation grade increased significantly over time. CONCLUSIONS: With excellent functional recovery of the patients, good systolic valve function, and overall low morbidity at 2 years, transcatheter aortic valve implantation may be considered the treatment of choice for aortic valve stenosis in elderly patients with an increased risk for surgery with a heart-lung machine.

Long-term performance of the Hancock bioprosthetic valved conduit in the aortic root position.

BACKGROUND AND AIM OF THE STUDY: The study aim was to assess long-term morbidity and mortality with special regard to prosthesis durability after aortic root replacement with the Hancock bioprosthetic porcine conduit. METHODS: Between 1975 and 2004, a total of 81 patients (55 males, 26 females; mean age 58 +/- 18 years) underwent aortic root replacement with the Hancock conduit for aortic dissection (n = 22; 27%), ascending aortic aneurysm (n = 57; 70%), or porcelain aorta (n = 2; 3%). Twenty-five patients (31%) underwent an emergency operation, 12 (15%) presented with Marfan syndrome, and eight (10%) had undergone previous cardiac surgery. Concomitant procedures were performed in 26 cases (32%). The follow up was 98% complete; the mean follow up was 4.8 +/- 4.0 years (range: 1 day to 16.7 years), and the cumulative follow up was 403 patient-years. Actuarial event-free rates were calculated, and valve-related complications classified according to guidelines for reporting morbidity and mortality after cardiac valvular operations. RESULTS: There were seven (9%) operative deaths and four (5%) in-hospital deaths. Actuarial survival rates at five and 10 years (excluding operative deaths) were 77.0 +/- 5.3% and 54.0 +/- 7.5%, respectively. Actuarial freedom from aortic valve reoperation at five and 10 years was 98 +/- 1.6% and 64 +/- 10.2%, from structural valve deterioration 88.1 +/- 4.7% and 49.9 +/- 9.6%, from thromboembolic events 87.4 +/- 4.6% and 75.1 +/- 9.5%, and from major bleeding events 90.2 +/- 3.9% and 75.4 +/- 8.1%, respectively. Among redo procedures, the stentless Hancock valve could be excised without separating the synthetic graft from the left ventricular outflow tract, and a stented valve prosthesis thus implanted. Hence, it was possible to avoid a second Bentall operation. CONCLUSION: The long-term survival rates after aortic root replacement with the bioprosthetic Hancock conduit were reasonable for this demanding patient cohort. However, the durability of the prosthesis was inferior to that reported for the stented Hancock valve substitute. The key benefit of this bioprosthetic valved conduit was the simplified redo procedure.

Incidence and predictors of acute kidney injury in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Acute kidney injury (AKI) can occur in up to one third of patients after surgical aortic valve replacement and can be associated with increased mortality. Little data exist, however, about the incidence, predictors, and prognostic implications of AKI after transcatheter aortic valve implantation (TAVI). OBJECTIVES: The aim of this study was to examine the incidence, predictors, and prognostic implications of AKI after TAVI. METHODS: Between January 2007 and January 2010, we prospectively enrolled 234 consecutive patients who underwent TAVI with the Medtronic CoreValve System (Medtronic CoreValve, Minneapolis, Minnesota) or Edwards SAPIEN (Edwards Lifesciences, Inc, Irvine, CA) heart valve. Acute kidney injury was defined according to the risk, injury, failure, loss, end-stage criteria. Patients with preoperative end-stage renal failure requiring dialysis were excluded. Baseline characteristics and procedural-related factors were examined as predictors for AKI in a multivariable regression model. RESULTS: Acute kidney injury was identified in 46 (19.6%) of 234 patients, and 24 (10.3%) of 234 patients required renal replacement therapy. The unadjusted in-hospital mortality rate was 15.2% in those patients without AKI and 7.7% in those with AKI (P = .015). Univariable logistic regression analysis identified preoperative serum creatinine, preoperative blood urea nitrogen, peripheral vascular disease, and blood transfusion to be associated with AKI. Preoperative serum creatinine level remained as the only independent predictor of AKI (OR 3.7 95%, CI 1.24-11.3, P = .019). The amount of contrast used (in milliliters) was not associated with AKI (OR 1.8 95%, CI 0.94-3.5, P = .07). CONCLUSION: In this study, we observed that one fifth of patients developed AKI after TAVI and that AKI was associated with increased in-hospital mortality. Preoperative serum creatinine level was identified as the only predictor of AKI.

Aortic annulus evaluation in transcatheter aortic valve implantation.

OBJECTIVES: We compared the annulus diameters measured by transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), and dual-source computed tomography (DSCT) before transcatheter aortic valve implantation (TAVI). BACKGROUND: In TAVI correct evaluation of the aortic annulus is mandatory to choose the correct prosthesis type and size and to prevent complications. There is no gold standard for the assessment of aortic annulus diameters. METHODS: Preoperative assessment of the aortic annulus with TTE, TEE, and DSCT was performed in 187 consecutive patients referred for TAVI between June 2007 and May 2009. RESULTS: The mean aortic annuli were 22.6 ± 2.0 mm measured with DSCT, 22.3 ± 2.5 mm with TTE, and 22.9 ± 2.2 mm with TEE. Despite a strong correlation between the measurement techniques, relevant statistical spread occurred with differences up to 3 mm in all measurement methods. Inter- and intraobserver variability was good for TEE and less satisfactory for DSCT measurements. TEE measurements taken as decisive parameter for the implantation changed the implantation strategy in 15.5% of patients and did not show an increased rate of procedural complications. CONCLUSION: Despite a strong correlation, the measurement techniques for the aortic annulus show relevant statistical spread, consequently one measurement technique cannot definitely predict another. TEE measurements show a more satisfactory intra- and interobserver variability than DSCT. Taking TEE annulus measurements as decisive parameter for the implantation has an impact on the implantation strategy and is safe with a low rate of procedural complications.