Continuous in situ targeted antibiotics for late cardiovascular implantable electronic device pocket perforation.

CIED infections are a dreaded complication associated with significant morbidity and mortality and the mainstay of treatment has traditionally been extraction. A recent cohort study suggested that continuous, in situ-targeted, ultrahigh concentrations of antibiotics (CITA) delivered into the CIED pocket may be a viable alternative to extraction in selected cases. We highlight two cases of device perforation which were successfully treated with this technique.

How should I treat severe symptomatic aortic stenosis with transcatheter aortic valve implantation in a patient with right aortic arch?

BACKGROUND: An 84-year-old man suffering from dyspnoea on mild exertion and a 10-year history of mitral valve replacement with a mechanical prosthesis presented to our department. The patient had an isolated right aortic arch. INVESTIGATION: Transthoracic echocardiography demonstrated severe LV systolic dysfunction (EF 25%), good function of the previously implanted mechanical prosthesis and severe aortic stenosis. Multislice computed tomography confirmed the presence of an isolated right aortic arch with mirror-image branching. DIAGNOSIS: Severe symptomatic aortic stenosis in a patient with right aortic arch at high risk for surgical reintervention. MANAGEMENT: Transcatheter aortic valve implantation using conventional delivery system.

Decrease of pulmonary hypertension impacts on prognosis after transcatheter aortic valve replacement.

AIMS: Transcatheter aortic valve replacement (TAVR) is established as a treatment strategy for patients with end-stage aortic stenosis, many of whom are suffering from severe pulmonary hypertension (PH). In cardiac surgery patients, PH is associated with less symptomatic improvement and increased late mortality. This study elucidates the impact of PH on outcome after TAVR. METHODS AND RESULTS: Pre and 90 days post-TAVR, pulmonary artery systolic pressure (PASP) was determined non-invasively by echocardiography in 353 patients undergoing TAVR. PH was classified as absent (<30 mmHg), mild-to-moderate (30-60 mmHg), and severe (>60 mmHg). Three hundred and fifty-three patients at high surgical risk, indicated by a logistic EuroSCORE of 26.6±16.5%, underwent TAVR. The severity of PH before TAVR was related to outcome with two-year mortality rates of 13.9%, 27.3%, and 48.4% for PASP <30 mmHg, 30-60 mmHg, and >60 mmHg, respectively (p=0.001). In patients with baseline PASP >60 mmHg, PASP decreased from 65.6±7.6 mmHg to 49.5±14.0 mmHg (p<0.001) at 90 days after TAVR. Patients with persistent severe PH had a worse prognosis than patients with a decrease of PASP below 60 mmHg (two-year mortality rate: 50.0% vs. 18.6%; p=0.001). CONCLUSIONS: Severe pulmonary hypertension predicts adverse outcome after TAVR. Reduction of PASP after the procedure is associated with favourable prognosis.

Evaluation and management of paravalvular aortic regurgitation after transcatheter aortic valve replacement.

Paravalvular aortic regurgitation (PAR) negatively affects the prognosis after transcatheter aortic valve replacement (TAVR) with dramatically increased morbidity and mortality in patients with more than mild PAR. Because transcatheter heart valves are implanted in a sutureless fashion using oversizing to anchor the prosthesis stent frame at the level of the virtual aortic annulus, stent frame underexpansion due to heavily calcified cusps, suboptimal placement of the prosthesis, and/or annulus-prosthesis-size mismatch due to malsizing can contribute to paravalvular leakage. In contrast to open heart surgery, TAVR does not offer the opportunity to measure the aortic annulus under direct vision during the procedure. Therefore, the dilemma before each TAVR procedure is the appropriate sizing of the dimensions of the aortic annulus and to choose not only the size but also the transcatheter heart valve type (self-expanding vs. balloon-expandable) that fits the given anatomy best. Because precise echocardiographic quantification of PAR in patients with TAVR remains challenging especially in the acute implantation situation, a multimodal approach for the evaluation of PAR with the use of hemodynamic measurements and imaging modalities is imperative to precisely quantify the severity of aortic regurgitation immediately after valve implantation and to identify patients who will benefit from corrective measures such as post-dilation or valve-in-valve implantation. Every measure has to be taken to prevent or reduce PAR to provide a satisfying long-term clinical outcome.

Differences in performance of five types of aortic valve prostheses: haemodynamic assessment by dobutamine stress echocardiography.

BACKGROUND: In patients being considered for aortic valve replacement, there remains controversy over which design or tissue offers the best performance. We aimed to evaluate in a single study the haemodynamic performances of five different widely used aortic valve prostheses: stentless porcine xenograft (Elan), stentless bovine pericardium (Pericarbon Freedom), stented porcine xenograft (Aspire), stented bovine pericardium (More) and mechanical (Ultracor). We also compared them with normal aortic valves and stenosed valves of variable severity. METHODS AND RESULTS: Preoperative echocardiography and dobutamine stress echocardiography at 1 year postoperatively were undertaken in 106 patients (n=18-24 from each group). Stentless bioprostheses, whether porcine or bovine, displayed superior haemodynamics across nearly all echocardiographic parameters: lower gradients, larger effective orifice area, higher dimensionless severity index (DSI) and lower resistance, when compared with stented or mechanical prostheses. Comparing both stented designs, bovine tissue performed the worst at rest, but with stress, there was no difference. The stress performances of the stentless bioprostheses were similar to the mildly stenosed native aortic valve, whereas the performances of the stented and mechanical prostheses resembled that of native valves with mild-to-moderate stenoses. Haemodynamic differences, however, did not translate into differences in left ventricular mass reduction at 1 year. CONCLUSIONS: Stentless bioprostheses displayed haemodynamics superior to stented or mechanical prostheses and had the closest performance to a normal, native aortic valve. Stress DSI data, least reliant on variable annulus/valve sizes and flow rates, provided the best haemodynamic discrimination.

Impact of paravalvular leakage on outcome in patients after transcatheter aortic valve implantation.

OBJECTIVES: The aim of this study was to evaluate the performance of the aortic regurgitation (AR) index as a new hemodynamic parameter in an independent transcatheter aortic valve implantation (TAVI) cohort and validate its application. BACKGROUND: Increasing evidence associates more-than-mild periprosthetic aortic regurgitation (periAR) with increased mortality and morbidity; therefore precise evaluation of periAR after TAVI is essential. The AR index has been proposed recently as a simple and reproducible indicator for the severity of periAR and predictor of associated mortality. METHODS: The severity of periAR was evaluated by echocardiography, angiography, and periprocedural measurement of the dimensionless AR index = ([diastolic blood pressure - left ventricular end-diastolic pressure]/systolic blood pressure) × 100. A cutoff value of 25 was used to identify patients at risk. RESULTS: One hundred twenty-two patients underwent TAVI by use of either the Medtronic CoreValve (Medtronic, Minneapolis, Minnesota) (79.5%) or the Edwards-SAPIEN bioprosthesis (Edwards Lifesciences, Irvine, California) (20.5%). The AR index decreased stepwise from 29.4 ± 6.3 in patients without periAR (n = 26) to 28.0 ± 8.5 with mild periAR (n = 76), 19.6 ± 7.6 with moderate periAR (n = 18), and 7.6 ± 2.6 with severe periAR (n = 2) (p < 0.001). Patients with AR index <25 had a significantly increased 1-year mortality rate compared with patients with AR index ≥ 25 (42.3% vs. 14.3%; p < 0.001). Even in patients with none/mild periAR, the 1-year mortality risk could be further stratified by an AR index <25 (31.3% vs. 14.3%; p = 0.04). CONCLUSIONS: The validity of the AR index could be confirmed in this independent TAVI cohort and provided prognostic information that was complementary to the severity of AR.

Comparison of complete versus incomplete stent frame expansion after transcatheter aortic valve implantation with Medtronic CoreValve bioprosthesis.

We sought to determine the significance of incomplete stent frame expansion after transcatheter aortic valve implantation with the Medtronic-CoreValve device. Incomplete coronary stent expansion is a well-described phenomenon. Transcatheter valves are mounted on stents; however, the incidence of incomplete stent expansion after transcatheter aortic valve implantation, its sequelae and predictors are poorly elucidated. The 18Fr CoreValve revalving system was used to treat anatomically and clinically suitable patients with severe calcific aortic stenosis. The postdeployment stent dimensions were measured on fluoroscopic images at multiple levels of the stent frame. Incomplete expansion at each was defined as <100% expected and complete expansion as ≥100%. These parameters were correlated to the hemodynamic and clinical end points. A total of 50 consecutive patients underwent transcatheter aortic valve implantation with the Medtronic-CoreValve at a single center from January 2007 to December 2008. For the inflow portion, incomplete expansion was seen in 54% of patients and was unrelated to the aortic valve area, peak or mean aortic valve gradients, or measures of aortic regurgitation, although it was paradoxically associated with a lower incidence of prosthesis-patient mismatch. Incomplete expansion of the constrained portion was seen in 62% of the patients and displayed a trend toward a greater incidence of aortic regurgitation grade 2 or greater, although this was rare. Incomplete expansion of the Medtronic CoreValve stent frame is common. For the most part, valvular hemodynamic function was satisfactory, regardless of the degree of expansion of the stent frame that carries it and a strategy of reluctant postdilation in the context of incomplete stent frame expansion was supported.

Anatomic suitability for present and next generation transcatheter aortic valve prostheses: evidence for a complementary multidevice approach to treatment.

OBJECTIVES: This study sought to assess the proportion of patients anatomically suitable for transcatheter aortic valve implantation by multiple access approaches. BACKGROUND: The devices currently in mainstream use for transcatheter treatment of severe aortic stenosis are those of Edwards (Edwards Lifesciences, Nyon, Switzerland) and Medtronic CoreValve (M-C) (Luxembourg City, Luxembourg). The range of patients that these can presently treat requires elucidation to guide the necessary evolution of these technologies and increase their scope of therapy. METHODS: A consecutive series of patients were assessed with transthoracic or transesophageal echocardiography and invasive angiography to assess anatomical suitability by different approaches. The transfemoral access requirements for Edwards and M-C (Edwards currently 22- and 24-F, soon to be 18- and 19-F; M-C 18-F) as well as the aortic valve annular criteria (18 to 25 mm and 20 to 27 mm, respectively) were incorporated in this assessment. Patients unsuitable for the transfemoral approach were considered for Edwards transapical and M-C transaxillary and direct ascending aortic access. Patients suitable for these devices and access approaches were identified. RESULTS: Data were analyzed for 100 consecutive patients. Edwards suitability was 28% for Edwards-Sapien transfemoral, 78% for Edwards Novaflex transfemoral, and 88% for Edwards-Sapien transapical. Medtronic CoreValve suitability was 84% for transfemoral and 89% using additional transaxillary and direct aortic approaches. Of the 12 patients unsuitable for Edwards-based procedures, 8 were suitable for M-C. Of the 11 patients unsuitable for M-C-based techniques, 8 were suitable for Edwards. Only 3% were anatomically unsuitable for all approaches. CONCLUSIONS: In this series, 97% of patients were anatomically suitable for a complementary approach to treatment.

Prosthesis-patient mismatch after transcatheter aortic valve implantation with the Medtronic-Corevalve bioprosthesis.

AIMS: Prosthesis-patient mismatch (P-PM) is an important determinant of morbidity and mortality following open aortic valve replacement. The aims of this study were to report its incidence and determinants following transcatheter aortic valve implantation (TAVI) with the Corevalve bioprosthesis, which have-thus far-not been described. METHODS AND RESULTS: Patients with severe calcific aortic stenosis received TAVI with the Corevalve bioprosthesis via transfemoral route. Following TAVI, moderate P-PM was defined as indexed aortic valve effective orifice area (AVAi) < or =0.85 cm(2)/m(2) and severe P-PM as AVAi < or =0.65 cm(2)/m(2). Clinical, echocardiographic, and procedural factors relating to P-PM were studied. Optimal device position was defined on fluoroscopy as final position of the proximal aspect of the Corevalve stent frame 5-10 mm below the native aortic annulus. Between January 2007 and January 2009, 50 consecutive patients underwent TAVI in a single centre with the Corevalve bioprosthesis. Mean age was 82.8 years (SD 5.9; 70-93) and 48% were male. P-PM occurred in 16 of 50 cases (32%). Optimal position was achieved in 50% of cases. P-PM was unrelated to age, annulus size, LVOT size, Corevalve size, aortic angulation, ejection fraction, and sex. It was inversely correlated to optimal position (Spearman rho r = -0.34, P = 0.015). Those with optimal positioning had a 16% incidence of P-PM relative to 48% of those with suboptimal positioning (Pearson chi(2) P = 0.015). CONCLUSION: The incidence of P-PM following TAVI with the Corevalve bioprosthesis is compared favourably with that seen after AVR with conventional open stented bioprostheses and its occurrence is influenced by device positioning.

Early regression of left ventricular wall thickness following percutaneous aortic valve replacement with the CoreValve bioprosthesis.

BACKGROUND/AIMS: Severe aortic stenosis (AS) is associated with hypertrophy of the left ventricle (LVH), which is linked to adverse clinical outcomes. To date, the effects of the novel technology of percutaneous aortic valve replacement (PAVR) on LVH in severe AS have not been described. We sought to test the hypothesis that PAVR would result in regression of LVH associated with severe AS. METHODS: Patients were recruited as part of a single-arm, prospective, safety, feasibility and clinical outcome study of the third-generation CoreValve percutaneous aortic bioprosthesis. To assess hypertrophy at baseline and at 1 month, the parasternal long-axis view in end-diastole was used to assess interventricular septal dimension and left ventricular posterior wall dimension. RESULTS: 15 patients were studied. There were significant periprocedural reductions in peak (76.6 +/- 28.1 mmHg to 16.3 +/- 7.5 mmHg; p < 0.001) and mean (45.3 +/- 18.4 mmHg to 8.2 +/- 3.7 mmHg; p = 0.001) transvalvular gradients and increases in calculated aortic valve areas (0.73 +/- 0.19 cm2 to 1.5 +/- 0.3 cm2). Septal wall thickness regressed by 13% from 1.54 +/- 0.30 cm at baseline to 1.35 +/- 0.27 cm at 1 month (for difference; p = 0.002). CONCLUSION: We demonstrate an early regression of septal hypertrophy after PAVR for severe AS which is comparable to that seen at 1 year after conventional surgical aortic valve replacement.

Predictors for permanent pacemaker requirement after transcatheter aortic valve implantation with the CoreValve bioprosthesis.

INTRODUCTION: Changes in atrioventricular (AV) conduction and need for permanent pacemaker (PPM) are a recognized complication after open aortic valve replacement. We hypothesized that the need for PPM after CoreValve (Corevalve Inc, Irvine, CA) can be predicted with a combination of baseline variables. METHODS: In patients undergoing transcatheter aortic valve implantation, potential clinical, electrocardiographic and echocardiographic predictors of permanent pacing requirement were studied. RESULTS: Between January 2007 and March 2008, 34 patients with severe symptomatic aortic stenosis were recruited in a single center. Mean age was 84.4 years (SD 5.4, range 71-93). Of 34 cases paced at baseline, 3 (8.8%) were excluded from this analysis, as was the single periprocedural mortality. Of the remaining 30, 10 underwent permanent pacemaker implantation during the same admission (33.3%). PPM was for prolonged high-grade AV block in 4 cases, episodic high-grade AV block in 5, and sinus node disease in 1. Need for pacemaker was correlated to left axis deviation at baseline (P = .004, r = 0.508) and left bundle-branch block with left axis deviation (P = .002, r = 0.548). It was related to diastolic interventricular septal dimension on transthoracic echocardiography >17 mm (P = .045, r = 0.39) and the baseline thickness of the native noncoronary cusp (P = .002, r = 0.655). A susceptibility model was generated, and if at least one of (1) left bundle-branch block with left axis deviation, (2) interventricular septal dimension >17 mm, or (3) noncoronary cusp thickness >8 mm was present, the likelihood of PPM could be predicted with 75% sensitivity and 100% specificity and a receiver operating characteristic curve area of 0.93 +/- 0.055 (P < .001). CONCLUSIONS: After transcatheter aortic valve implantation with CoreValve, permanent pacing was performed in around a third of patients and we present preliminary concepts towards a predictive model for this phenomenon.

Echocardiography for transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a new technology that treats severe aortic stenosis. The technology has specific and mandatory technical requirements that must be met to allow safe and successful procedures. The echocardiographic method for diagnosis of aortic stenosis, anatomical case selection, procedural guidance and management of complications is discussed in this context. The role of the imaging specialist is defined within the TAVI team aiming to provide good outcomes for this high risk cohort of patients.

Percutaneous aortic valve replacement in patients with challenging aortoiliofemoral access.

Percutaneous aortic valve replacement (PAVR) offers considerable promise in treating high risk patients with aortic valve disease. Two devices are currently clinically available for transfemoral delivery: the Edwards-Sapien balloon-expandable bioprosthesis and the Corevalve self-expanding bioprosthesis, both of which require careful sizing of the peripheral vasculature. Through a case based discussion, we illustrate that these limits of PAVR technology can be stretched in cases of extraordinary clinical need. We demonstrate that, following a learning curve of "optimal cases," successful PAVR is also possible in diffusely diseased peripheries of borderline small size or with focal aortoiliofemoral disease amenable to a separate intervention beforehand.

Video-assisted thoracoscopic implantation of the left ventricular pacing lead for cardiac resynchronization therapy.

BACKGROUND: To study the feasibility and efficacy of video-assisted thoracoscopic (VAT) placement of the left ventricular pacing lead for cardiac resynchronization therapy (CRT) where the conventional transvenous coronary sinus approach has failed. METHODS: Seventeen patients underwent the VAT procedure. Indications for CRT were ischemic cardiomyopathy in six patients and nonischemic cardiomyopathy in 11. The procedure was performed under general anesthesia with single-lung ventilation. Three 2-cm incisions were used on the left chest wall to place the screw-in lead near the obtuse marginal arteries high on the lateral wall of the left ventricle (LV). RESULTS: The VATS approach was successful in 13/17 (76%) patients. Median procedure time was 75 minutes (range 55-135). A learning curve was observed that appeared to plateau at 75 minutes procedure time after four cases. Median length of hospital stay was 2 days (range 2-8) with one patient requiring intensive care. Satisfactory thresholds and impedances of 2.3 +/- 0.9 V/0.5 ms and 560 ohms, respectively, were achieved at mean follow-up of 226 days. All patients reported symptomatic benefit with reduction in New York Heart Association score from III preoperatively to II postoperatively. CONCLUSIONS: VAT placement of the epicardial pacing lead is feasible, safe, and efficacious. It should be considered in cases where the transvenous route has failed or as an alternative in prolonged or hazardous transvenous procedures.

Randomized, controlled trial of intramuscular or intracoronary injection of autologous bone marrow cells into scarred myocardium during CABG versus CABG alone.

BACKGROUND: Studies of the transplantation of autologous bone marrow cells (BMCs) in patients with chronic ischemic heart disease have assessed effects on viable, peri-infarct tissue. We conducted a single-blinded, randomized, controlled study to investigate whether intramuscular or intracoronary administration of BMCs into nonviable scarred myocardium during CABG improves contractile function of scar segments compared with CABG alone. METHODS: Elective CABG patients (n = 63), with established myocardial scars diagnosed as akinetic or dyskinetic segments by dobutamine stress echocardiography and confirmed at surgery, were randomly assigned CABG alone (control) or CABG with intramuscular or intracoronary administration of BMCs. The BMCs, which were obtained at the time of surgery, were injected into the mid-depth of the scar in the intramuscular group or via the graft conduit supplying the scar in the intracoronary group. Contractile function was assessed in scar segments by dobutamine stress echocardiography before and 6 months after treatment. RESULTS: The proportion of patients showing improved wall motion in at least one scar segment after BMC treatment was not different to that observed in the control group (P = 0.092). Quantitatively, systolic fractional thickening in scar segments did not improve with BMC administration. Furthermore, BMCs did not improve scar transmurality, infarct volume, left ventricular volume, or ejection fraction. CONCLUSION: Injection of autologous BMCs directly into the scar or into the artery supplying the scar is safe but does not improve contractility of nonviable scarred myocardium, reduce scar size, or improve left ventricular function more than CABG alone.

Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation: a randomized controlled trial.

CONTEXT: Although left atrial radiofrequency ablation (RFA) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery, its efficacy to restore sinus rhythm and any resulting benefits have not been examined in the context of an adequately powered randomized trial. OBJECTIVE: To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003. A total of 101 patients referred for mitral valve surgery with at least 6 months' history of uninterrupted atrial fibrillation were assessed for eligibility; 97 were enrolled. Patients were followed up for 12 months. INTERVENTION: Patients were randomly assigned to undergo mitral valve surgery and RFA of the left atrium (n = 49) or mitral valve surgery alone (controls; n = 48). MAIN OUTCOME MEASURES: The primary outcome measure was presence of sinus rhythm at 12 months; secondary measures were patient functional status and exercise capacity (assessed by shuttle-walk test), left atrial contractility, and left atrial and left ventricular dimension and function and plasma levels of B-type natriuretic peptide. RESULTS: At 12 months, sinus rhythm was present in 20 (44.4%) of 45 RFA patients and in 2 (4.5%) of 44 controls (rate ratio, 9.8; 95% CI, 2.4-86.3; P<.001). Restoration of sinus rhythm in the RFA group was accompanied by a greater improvement in mean (SD) shuttle-walk distance compared with controls (+94 [102] m vs +48 [82] m; P = .003) and a greater reduction in the plasma level of B-type natriuretic peptide (-104 [87] fmol/mL vs -51 [82] fmol/mL; P = .03). Patients randomized to receive RFA had similar rates of postoperative complications and deaths as control patients. CONCLUSIONS: Radiofrequency ablation of the left atrium during mitral valve surgery for continuous atrial fibrillation significantly increases the rate of sinus rhythm restoration 1 year postoperatively, improving patient exercise capacity. On the basis of its efficacy and safety, routine use of RFA of the left atrium during mitral valve surgery may be justified. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00238706.