Percutaneous complete repair of failed mitral valve prosthesis: simultaneous closure of mitral paravalvular leaks and transcatheter mitral valve implantation - single-centre experience.

AIMS: Structural deterioration and paravalvular leak (PVL) are complications associated with surgically implanted prosthetic valves, historically requiring reoperation. We present our experience of complete transcatheter repair of a degenerated mitral bioprosthesis. METHODS AND RESULTS: From March 2012 to October 2012, we reviewed consecutive, high-risk surgical patients (n=5) who underwent transcatheter repair of a failed mitral bioprosthesis with severe paravalvular regurgitation (PVR). Manufacturer valve sizes ranged from 27 to 33 mm, regurgitation (n=1), stenosis (n=1), or both (n=3). Percutaneous transapical and transseptal access were achieved with PVL closure performed transapically. An arteriovenous rail was created for transseptal delivery of a Melody valve. All patients had successful PVL closure with no residual PVR. Valve-in-valve (ViV) implantation was successful in four patients. Overall, mean transvalvular mitral gradient was 11.2 mmHg pre-procedure which improved to 5 mmHg post-procedure. Improvement of NYHA Class ≥2 was achieved in all patients (19±3 months). One patient had controlled Melody valve embolisation which required emergent surgical replacement. Inner valve diameter was 26 mm, too large for Melody valve implantation. CONCLUSIONS: Complete transcatheter repair of a degenerated mitral bioprosthesis with PVR can be performed in the high-risk patient. Accurate measurement is necessary prior to intervention, with concern for embolisation among the larger valve sizes (>31 mm).

CT angiography-fluoroscopy fusion imaging for percutaneous transapical access.

OBJECTIVES: The aim of this proof-of-principle study is to validate the accuracy of fusion imaging for percutaneous transapical access (TA). BACKGROUND: Structural heart disease interventions, including TA, are commonly obtained under fluoroscopic guidance, which lacks important spatial information. Computed tomographic angiography (CTA)-fluoroscopy fusion imaging can provide the 3-dimensional information necessary for improved accuracy in planning and guidance of these interventions. METHODS: Twenty consecutive patients scheduled for percutaneous left ventricular puncture and device closure using CTA-fluoroscopy fusion guidance were prospectively recruited. The HeartNavigator software (Philips Healthcare, Best, the Netherlands) was used to landmark the left ventricular epicardium for TA (planned puncture site [PPS]). The PPS landmark was compared with the position of the TA closure device on post-procedure CTA (actual puncture site). The distance between the PPS and actual puncture site was calculated from 2 fixed reference points (left main ostium and mitral prosthesis center) in 3 planes (x, y, and z). The distance from the left anterior descending artery at the same z-plane was also assessed. TA-related complications associated with fusion imaging were recorded. RESULTS: The median (interquartile range [IQR]) TA distance difference between the PPS and actual puncture site from the referenced left main ostium and mitral prosthesis center was 5.00 mm (IQR: 1.98 to 12.64 mm) and 3.27 mm (IQR: 1.88 to 11.24 mm) in the x-plane, 4.48 mm (IQR: 1.98 to 13.08 mm) and 4.00 mm (IQR: 1.62 to 11.86 mm) in the y-plane, and 5.57 mm (IQR: 3.89 to 13.62 mm) and 4.96 mm (IQR: 1.92 to 11.76 mm) in the z-plane. The mean TA distance to the left anterior descending artery was 15.5 ± 7.8 mm and 22.7 ± 13.7 mm in the x- and y-planes. No TA-related complications were identified, including evidence of coronary artery laceration. CONCLUSIONS: With the use of CTA-fluoroscopy fusion imaging to guide TA, the actual puncture site can be approximated near the PPS. Moreover, fusion imaging can help maintain an adequate access distance from the left anterior descending artery, thereby, potentially reducing TA-related complications.

Combined photodynamic therapy and intravitreal triamcinolone for nonsubfoveal choroidal neovascularization.

PURPOSE: To examine the 12-month results for a group of patients with nonsubfoveal choroidal neovascularization who were treated with combined photodynamic therapy (PDT) with verteporfin and intravitreal triamcinolone acetonide. METHODS: Patients with nonsubfoveal choroidal neovascularization, which was defined as either juxtafoveal or extrafoveal neovascularization, were treated with PDT immediately followed by an intravitreal injection of 4 mg of triamcinolone acetonide. Need for retreatment was based on fluorescein angiographic evidence of leakage at 3-month follow-up intervals. The main outcome measures were visual acuity and the proportion of patients developing subfoveal extension. RESULTS: Of the 15 patients, 9 were women and 6 were men (mean age +/- SD, 80 +/- 7.5 years). The mean baseline visual acuity was almost 20/60 (mean logMAR = 0.46), and 14 of the 15 eyes had juxtafoveal choroidal neovascularization. At 3, 6, and 9 months, the patients had significant improvement in the mean visual acuity (P = 0.002, 0.001, and 0.007, respectively), but at the end of the 12-month follow-up period, the mean visual acuity was slightly worse than 20/40 (mean logMAR = 0.34), which was not statistically significant at an alpha level adjusted for multiple comparisons of .013 (P = .057) as compared with the baseline visual acuity. One patient had subfoveal extension of choroidal neovascularization. The mean number of treatments was 1.9. Three patients (20%) developed an intraocular pressure of >24 mmHg during follow-up, a threshold used to institute pressure reduction therapy. No patient developed endophthalmitis. CONCLUSION: The number of patients in this pilot study was limited; however, the visual acuity response and the low incidence of subfoveal extension suggest that PDT combined with intravitreal triamcinolone for the treatment of nonsubfoveal choroidal neovascularization merits further investigation as a first-line treatment.

Photodynamic therapy with verteporfin combined with intravitreal injection of triamcinolone acetonide for choroidal neovascularization.

PURPOSE: To examine the 12-month results of a group of patients treated with combined photodynamic therapy (PDT) with verteporfin and intravitreal triamcinolone acetonide for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). DESIGN: Noncomparative case series. PARTICIPANTS: Twenty-six eyes of 26 patients with CNV secondary to AMD. Thirteen with CNV, without restriction to type, were not treated with prior PDT (newly treated group). Thirteen patients with prior PDT therapy who experienced visual loss while being treated with PDT alone comprised the remainder (prior PDT group). METHODS: Patients with CNV were treated with PDT, immediately followed by an intravitreal injection of 4 mg of triamcinolone acetonide. Visual acuity was measured by Early Treatment Diabetic Retinopathy Study protocol refraction. Need for retreatment was based on fluorescein angiographic evidence of leakage at 3-month follow-up intervals. MAIN OUTCOME MEASURES: Visual acuity and retreatment rate. RESULTS: In the newly treated group, the mean acuity change was an improvement of 2.5 lines (last observation carried forward [LOCF], +2.4 lines; P = 0.011, Wilcoxon signed ranks test, as compared with baseline acuity) for patients completing the 12-month follow-up. In the prior PDT group, the mean change was an improvement of +0.44 lines (LOCF, +0.31 lines; P = 0.53). Retreatment rates were 1.24 for the newly treated group and 1.2 for the prior PDT group over the first year. Ten patients (38.5%) developed an intraocular pressure (IOP) of >24 mmHg during follow-up, a threshold used to institute pressure reduction therapy. No patient developed endophthalmitis. CONCLUSION: Although the number of patients in this pilot study was limited, the improvement of acuity and the reduced treatment frequency in these patients suggest that combination therapy with PDT and intravitreal triamcinolone acetonide, particularly when used as first-line therapy, merits further investigation. Elevated IOP seems to be the most frequent early side effect of the treatment.

Intravitreal triamcinolone acetonide and intraocular pressure.

PURPOSE: To analyze the incidence of intraocular pressure (IOP) elevation following intravitreal triamcinolone injection. DESIGN: Retrospective observational case series. METHODS: Charts of patients undergoing intravitreal triamcinolone injection in one clinical practice were reviewed. A pressure elevation was defined as a pressure of 24 mm Hg or higher during follow-up. RESULTS: There were 89 patients with a mean age of 76.4 years. The mean baseline IOP was 14.9 mm Hg with a mean change of 8.0 mm Hg. Thirty-six patients (40.4%) experienced a pressure elevation to 24 mm Hg or higher at a mean of 100.6 days (SD = 83.1 day) after treatment. Of nonglaucomatous patients with baseline IOP of 15 mm Hg or above, 60.0% experienced a pressure elevation, compared with only 22.7% of those with baseline pressures below 15 mm Hg (relative risk = 2.1, P < .01). In glaucoma patients, 6 of 12 (50%) experienced a pressure elevation, and this elevation was not correlated with baseline pressure. Thirty-two patients (36.0%) received repeat injections, and there was no difference in the incidence of procedure elevation in patients receiving multiple injections versus those receiving a single injection. Pressure elevation was controlled with topical medications in all patients. CONCLUSIONS: IOP elevation after intravitreal triamcinolone injection is common and may take an extended period of time to manifest. The proportion of patients who developed a pressure elevation to at least 24 mm Hg was much higher for those with baseline IOP 15 mm Hg or greater.

Combined photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide for choroidal neovascularization.

PURPOSE: To examine combined photodynamic therapy (PDT) with verteporfin and intravitreal triamcinolone acetonide for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). DESIGN: Noncomparative case series. PARTICIPANTS: Twenty-six eyes of 26 patients with CNV secondary to AMD. Thirteen with CNV, without restriction to type, were not treated with prior PDT and were called the Newly Treated group. Thirteen patients with prior PDT therapy who experienced visual loss during treatment with PDT alone comprised the remainder and were termed the Prior PDT group. METHODS: Patients with CNV were treated with PDT immediately followed by an intravitreal injection of 4 mg of triamcinolone acetonide. Visual acuity was measured by Early Treatment Diabetic Retinopathy Study protocol refraction. Need for retreatment was based on fluorescein angiographic evidence of leakage at 3-month follow-up intervals. MAIN OUTCOME MEASURES: Visual acuity and retreatment rate. RESULTS: Of the 13 patients in the Newly Treated group the mean visual acuity change at 3 months was an improvement of 1.9 lines, and 4 (30.8%) had an improvement of at least 3 lines. Two patients (15.4%) required retreatment at 3 months. At the 6-month follow-up, available for 12 patients in the Newly Treated group, the mean visual acuity change from baseline was an improvement of 2.4 lines, 4 patients (33%) had an improvement of at least 3 lines and 1 patient required retreatment. At both time points the visual acuity was significantly greater than at baseline (P = 0.023 and P = 0.007, at the 3-month and 6-month time points, Wilcoxon signed ranks test) for patients in the Newly Treated group. Among the 13 patients in the Prior PDT group, the mean change in visual acuity from baseline at the 3-month follow-up was 0.31 lines and 1 patient (7.7%) had an improvement of at least 3 lines. Six-month follow-up was available for 11 patients in the Prior PDT group and the mean change from baseline visual acuity was 0.1 lines and 1 patient (9.1%) experienced an improvement of 3 or more lines. No patient in the Prior PDT group required retreatment at 3 or 6 months. At the 3-month and 6-month time points the visual acuity was not significantly different than the baseline acuity in the Prior PDT group. No patient in either group at any time point experienced a loss of visual acuity of 3 or more lines. Five patients (19.2%), 3 in the Newly Treated group and 2 in the Prior PDT group, required monodrop therapy to control their intraocular pressure. No patient developed endophthalmitis. CONCLUSION: Although the number of patients in this pilot study was limited, the improvement of acuity and the lack of fluorescein leakage in these patients suggest combination therapy with PDT and intravitreal triamcinolone acetonide, particularly when used as first-line therapy, merits further investigation.

Neutrophil margination as a possible mechanism for verteporfin infusion-associated pain.

PURPOSE: To investigate the changes in absolute neutrophil counts in patients with and without pain after verteporfin infusion. DESIGN: Experimental study. METHODS: The absolute neutrophil counts were obtained from the blood samples taken at the beginning of infusion and after the end of verteporfin infusion. RESULTS: Four patients in whom verteporfin infusion-related pain developed had a decrease in the absolute neutrophil counts from a preinfusion mean of 4,589/mm(3) to a postinfusion mean of 1,688/mm(3) while they had pain, as compared with preinfusion and postinfusion counts of 4,912/mm(3) and 4,111/mm(3), respectively, in five control patients having no pain, a difference in proportion that was significant (P =.027). CONCLUSIONS: Patients in this study with verteporfin infusion-associated pain developed neutropenia during infusion, most likely from drug-induced neutrophil margination. It is possible that medications preventing the transient neutropenia may help avert verteporfin infusion-associated pain.

Verteporfin infusion-associated pain.

PURPOSE: To determine if oral hydration decreases the incidence of verteporfin infusion-associated pain and to find out if other factors play a role in predisposing to this undesired complication. METHODS: Nonrandomized clinical trial. We prospectively examined 250 consecutive patients who have been diagnosed with subfoveal choroidal neovascularization secondary to age-related macular degeneration and received photodynamic therapy using verteporfin. One hundred twenty-five patients were assigned to receive 500 ml of water orally administered 30 minutes before beginning the verteporfin infusion, and the remaining 125 consecutive patients were used as controls. Historical and clinical factors in these patients were evaluated for their association with the presence of verteporfin infusion-associated pain. RESULTS: Out of 125 patients receiving water before treatment 12 (9.6%) experienced verteporfin infusion-associated pain. Among the 125 patients who did not get hydration before therapy 12(9.6%) experienced verteporfin infusion-associated pain. There was no statistical difference between the incidence of pain in the two groups (P = 1.0). No statistically significant association was evidenced between the presence of pain and participant's baseline characteristics, except for pain on previous administration of verteporfin (P < .001). Out of 250 total patients 24 (9.6%) developed verteporfin infusion-associated pain. Back pain was the most common and occurred in 21 (8.4%) patients, but other sites included leg, groin, chest, buttock, arm, and shoulder pain concurrently or independently. All patients had resolution of their pain, including chest pain, on cessation of the infusion. CONCLUSIONS: Verteporfin infusion-associated pain may be more common than has been previously reported and is not limited to the back area. It appears to be an idiosyncratic reaction to the drug. It does not seem to be prevented by oral hydration before infusion of verteporfin, and no baseline characteristics, other than a history of pain on previous infusion, seem to be predictive of verteporfin infusion-associated pain.