Health economic evaluation of single-lead atrial pacing vs. dual-chamber pacing in sick sinus syndrome.

AIMS: The recent Danish Multicentre Randomized Trial on Single-Lead Atrial (AAIR) Pacing versus Dual-Chamber (DDDR) Pacing in Sick Sinus Syndrome (DANPACE) suggested DDDR pacing as standard care. However, previous findings supported the routine use of AAIR pacing. This study investigated the cost-effectiveness of DDDR pacing compared with AAIR pacing for sick sinus syndrome. METHODS AND RESULTS: A decision-analytical model based on patient-level data from three randomized trials was designed from the Danish healthcare system's perspective. The main outcomes were lifetime costs, quality-adjusted lifeyears (QALYs), and net monetary benefit. Quality-adjusted lifeyears were calculated by utilizing community-based preferences. Costs were calculated by utilizing the extensive data on resource consumption, from the DANPACE trial. Data were pooled and adjusted for baseline differences. Dual-chamber pacing was shown to be cost-effective in all the analyses using a willingness-to-pay (WTP) threshold of £20,000/QALY, and most analyses using a WTP of £30,000/QALY. When pooling the data and adjusting for baseline differences, Monte Carlo simulations revealed a 51-71% probability of DDDR pacing being cost-effective at a WTP of £20,000/QALY, and a 42-58% probability at a WTP of £30,000/QALY. Dual-chamber pacing was most likely to be cost-effective among elderly patients with comorbidity. The expected value of perfect information was low and initiation of additional publicly funded Danish trials was discouraged. CONCLUSION: Dual-chamber pacing is likely to be a cost-effective treatment for sick sinus syndrome patients.

System upgrade and its complications in patients with a single lead atrial pacemaker: data from the DANPACE trial.

AIMS: To investigate the indications for system upgrade with single lead atrial pacing (AAIR), complications associated with these re-interventions, and possible predictors for system upgrade among patients included in the Danish Multicenter Randomized Trial on AAIR vs. dual-chamber pacing (DDDR) in sick sinus syndrome (DANPACE). METHODS AND RESULTS: A total of 707 of 1415 patients were randomized to AAIR pacing. Mean follow-up was 5.5 ± 2.6 years. Information on indications for system upgrade and complications were collected by reviewing patient charts. Multiple logistic regression was used to estimate adjusted odds ratios (aOR) with 95% confidence intervals (CI) for the association between predictors and system upgrade. Sixty-six patients (9.3%) in the AAIR group underwent system upgrade. Fifty-nine of these patients (89.3%) had a documented class I indication for system upgrade. Age (aOR 0.98 for each 1-year increase in age; 95% CI 0.6-1.0), and left atrial enlargement (aOR 1.9; 95% CI 1.0-3.8) were predictors for system upgrade. No single clinically applicable predictor for upgrade was identified. A total of 11 patients (16.7%) experienced at least one major complication after system upgrade. CONCLUSION: The majority of patients with AAIR pacing who underwent system upgrade had a class I indication. The incidence of major complications after system upgrade was high. The present data support the use of DDDR pacing rather than AAIR pacing in sick sinus syndrome.

Urban and rural implementation of pre-hospital diagnosis and direct referral for primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction.

AIMS: Primary percutaneous coronary intervention (PCI) is the preferred treatment for ST-elevation myocardial infarction (STEMI). The distance to primary PCI centres and the inherent time delay in delivering primary PCI, however, limit widespread use of this treatment. This study aimed to evaluate the impact of pre-hospital diagnosis on time from emergency medical services contact to balloon inflation (system delay) in an unselected cohort of patients with STEMI recruited from a large geographical area comprising both urban and rural districts. METHODS AND RESULTS: From February 2004 until January 2007, data on pre-hospital timing and transport distance were prospectively recorded. Patients were divided into groups depending on achievement of pre-hospital diagnosis and/or direct referral to a primary PCI centre. Seven hundred and fifty-nine consecutive STEMI patients were included. In patients with a pre-hospital diagnosis and direct referral, the system delay was 92 vs. 153 min in patients without pre-hospital diagnosis (P < 0.001). Patients from rural areas were transported a median of 30 km longer than patients from urban areas; however, this prolonged the system delay by only 9 min. CONCLUSION: Pre-hospital electrocardiographic (ECG) diagnosis and direct referral for primary PCI enables STEMI patients living far from a PCI centre to achieve a system delay comparable with patients living in close vicinity of a PCI centre.

Single center experience with transcatheter aortic valve implantation using the Edwards SAPIEN™ Valve.

OBJECTIVES: The use of transcatheter aortic valve implantation (TAVI) for high-risk patients was introduced in the early 2000s for treatment of aortic valve stenosis patients with too high surgical risk. During the last years, there has been a dramatic increase in TAVI procedures. TAVI programs are implemented in numerous cardiac centers. This paper describes a single center experience with its first 100 TAVI procedures. METHODS: This study included the first 100 patients who were scheduled for either transfemoral (F-TAVI) or transapical (A-TAVI) aortic valve implantation at Aarhus University Hospital, Skejby, using the Edwards SAPIEN™ valve. The indication for TAVI was unacceptable high predicted risk associated with conventional surgery. Patients with adequate diameter of iliac arteries were scheduled for F-TAVI, otherwise A-TAVI was preferred. RESULTS: The patients were treated between February 2006 and June 2010. Of these were 44% males and 56% females with a mean (S.D.) age of 81 (7.0). Thirty-days mortality rate was 8%, and decreased from 12% among the first 50 patients to 4% for the last 50 patients. Successful implantation was achieved in 92% patients. Major non-fatal complications were seen in 5% of 76 A-TAVI and in 0% of 24 F-TAVI patients. Mean (S.D.) EuroSCORE in the F-TAVI and A-TAVI groups was 15.9 (9.4) and 21.5 (14), respectively (p = 0.06). Post-procedural leakage of cardiac biomarkers was significantly higher in the A-TAVI group as compared to in the F-TAVI group. Mean (S.D.) NYHA class improved from 2.9 (0.6) to 1.8 (0.7) p < 0.001, with no significant difference between A-TAVI and F-TAVI patients. CONCLUSION: In surgically non-amenable patients, TAVI can be performed with acceptable mortality and morbidity and results in marked functional improvement. A decrease in 30-day mortality over time indicated a learning curve when implementing this treatment.

How Transcatheter Aortic Valve Implantation (TAVI) Was Born: The Struggle for a New Invention.

This story is about the invention of transcatheter aortic valve implantation (TAVI), and the people who transformed it from a concept and primitive device to a breakthrough lifesaving treatment for hundreds of thousands of patients with aortic valve stenosis. It is an inspirational example of a new disruptive technology that began with an idea most dismissed. The story describes the ups and downs from idea, design, construction, animal testing, proof-of-concept, scientific publication hurdles, a patent, license agreement, cooperation with several companies, fighting in patent courts in Europe and USA and finally how multinational companies financially bypassed the inventor. It is also a story about the struggles and battles the inventor experienced when injected into a world of lawyers and patent fights. I hope my personal story and journey can provide an inspiration and word of caution for new inventors.

History of percutaneous aortic valve prosthesis.

This review describes the development of percutaneous transluminal catheter-mounted heart valves for permanent implantation. The time period from the first surgically implanted valve in 1952, through catheter- mounted valves inserted for temporal relief, until the conception of the percutaneous transcatheter heart valve for permanent implantation is summarized. The process involved in the construction of the new valve is detailed in Figure 1, and the future of this new treatment modality is discussed.

ST changes before and during primary percutaneous coronary intervention predict final infarct size in patients with ST elevation myocardial infarction.

BACKGROUND: In patients with ST elevation myocardial infarction (STEMI), spontaneous ST resolution (spontSTR) is a marker of successful microvascular reperfusion. The significance of increase in ST elevation during reperfusion therapy (the ST peak phenomenon), however, is controversial. AIMS: The purpose of the study was to evaluate whether preprocedural and periprocedural ST changes predict final infarct size (IS) in STEMI patients treated with primary percutaneous coronary intervention (primary PCI). METHODS: Twelve-lead electrocardiograms (ECGs) were acquired in the prehospital phase and on admission in 200 STEMI patients transferred for primary PCI. Continuous ST monitoring was performed during and 90 minutes after primary PCI. The exact timing of interventional procedures and the resulting thrombolysis in myocardial infarction (TIMI) flow were registered. A 1-month single-photon emission computerized tomography was performed to evaluate IS. Patients were stratified into groups according to preprocedural and periprocedural ST changes as follows: patients with spontSTR before primary PCI and without (A) or with (B) ST peak during primary PCI and patients with persistent ST elevation before primary PCI and without (C) or with (D) ST peak during primary PCI. FINDINGS: Groups A (n = 45), B (n = 10), C (n = 109), and D (n = 36) differed with regard to IS (median, 2%, 3%, 13% vs 22% of the left ventricle; P < .0001). In multivariable analysis adjusting for baseline characteristics, preprocedural and periprocedural ECG findings and routine angiography findings, spontSTR was associated with smaller IS (B = -8.6%; P < .001), whereas the ST peak phenomenon was associated with larger IS (B = +5.0%; P = .006). There was no difference in TIMI flow grades in relation to coronary interventions among patients with and without ST peak during primary PCI. CONCLUSIONS: In STEMI patients, spontSTR before primary PCI and the ST peak phenomenon during primary PCI predict minor vs extensive IS independent of angiographic patency grades. Further studies are needed to clarify whether the ST peak phenomenon is "a marker of injury before reperfusion" or "a marker of reperfusion-induced injury."

Long-term outcome of primary angioplasty compared with fibrinolysis across age groups: a Danish Multicenter Randomized Study on Fibrinolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) substudy.

BACKGROUND: Primary angioplasty in patients with acute ST-elevation myocardial infarction has been shown to be superior to fibrinolysis. Whether elderly patients have the same long-term benefit from angioplasty, compared with fibrinolysis, as younger patients is unknown. METHODS: The effect of angioplasty versus fibrinolysis was investigated in 1,572 patients from the DANAMI-2 study across age groups. End points were total mortality and a composite end point of death, reinfarction, or disabling stroke. Follow-up was 3 years. RESULTS: Increasing age was associated with mortality (adjusted hazard ratio [HR] 2.45 per 10 year increment, 95% confidence interval [CI] 1.78-3.37, P < .0001) and a higher composite event rate (adjusted HR 1.51, CI 1.26-1.82, P < .0001). The long-term superiority of angioplasty over fibrinolysis on the combined outcome was independent of age: patients aged <56 years (HR 0.73, CI 0.41-1.31); 56 to 65 years (HR 0.83, CI 0.52-1.33); 66 to 75 years (HR 0.71, CI 0.48-1.04); and >75 years (HR 0.83, CI 0.59-1.17) (P = .006 for overall treatment effect and P = .5 for interaction between age and treatment). There was no long-term effect of angioplasty versus fibrinolysis on mortality and no interaction with age (P = .5 and P for interaction = .6). CONCLUSIONS: The long-term effect of primary angioplasty compared with fibrinolysis in patients with ST-elevation myocardial infarction is not affected by age.

Percutaneous coronary intervention for acute MI does not prevent in-hospital development of cardiogenic shock compared to fibrinolysis.

BACKGROUND: It has been speculated that invasive revascularization prevents development of cardiogenic shock. Data from randomised trials comparing angioplasty with fibrinolysis on the development of cardiogenic shock are lacking. AIMS: To elucidate the effect of angioplasty on in-hospital development of cardiogenic shock compared to fibrinolysis. To evaluate whether mortality in patients who develop cardiogenic shock after treatment is dependent on revascularization strategy. METHODS AND RESULTS: DANAMI-2 randomly assigned 1572 STEMI patients to fibrinolysis (782 patients) or angioplasty (790 patients). Data on patients with in-hospital development of cardiogenic shock after randomisation were included. Of the 103 patients (6.6%) patients developing cardiogenic shock 57% were randomised to angioplasty with an unadjusted odds ratio of 1.39 (0.92-2.11, p=0.14). During the three year follow-up 58% of the total mortality was due to cardiogenic shock, and treatment strategy did not influence the risk associated with shock (hazard ratio of 1.05 (0.67-1.64) for angioplasty vs. fibrinolysis). CONCLUSIONS: Angioplasty does not prevent the in-hospital development of cardiogenic shock complicating acute MI compared to fibrinolysis. Cardiogenic shock is still the leading cause of death in patients hospitalised for acute MI. There was no difference in mortality, with regards to treatment strategy in patients developing cardiogenic shock after the initial treatment.

Routine thrombectomy in percutaneous coronary intervention for acute ST-segment-elevation myocardial infarction: a randomized, controlled trial.

BACKGROUND: Distal embolization during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction may result in reduced myocardial perfusion, infarct extension, and impaired prognosis. METHODS AND RESULTS: In a prospective randomized trial, we studied the effect of routine thrombectomy in 215 patients with ST-segment-elevation myocardial infarction lasting <12 hours undergoing primary PCI. Patients were randomized to thrombectomy pretreatment or standard PCI. The primary end point was myocardial salvage measured by sestamibi SPECT, calculated as the difference between area at risk and final infarct size determined after 30 days (percent). Secondary end points included final infarct size, ST-segment resolution, and troponin T release. Baseline variables, including ST-segment elevation and area at risk, were similar. Salvage was not statistically different in the thrombectomy and control groups (median, 13% [interquartile range, 9% to 21%] and 18% [interquartile range, 7% to 25%]; P=0.12), but 24 patients in the thrombectomy group and 12 patients in the control group did not have an early SPECT scan, mainly because of poor general or cardiac condition (P=0.04). In the thrombectomy group, final infarct size was increased (median, 15%; [interquartile range, 4% to 25%] versus 8% [interquartile range, 2% to 18%]; P=0.004). CONCLUSIONS: Thrombectomy performed as routine therapy in primary PCI for ST-elevation myocardial infarction does not increase myocardial salvage. The study suggests a possible deleterious effect of thrombectomy, resulting in an increased final infarct size, and does not support the use of thrombectomy in unselected primary PCI patients.

Timing of ischemic onset estimated from the electrocardiogram is better than historical timing for predicting outcome after reperfusion therapy for acute anterior myocardial infarction: a DANish trial in Acute Myocardial Infarction 2 (DANAMI-2) substudy.

BACKGROUND: Acute treatment strategy and subsequently prognosis are influenced by the duration of ischemia in patients with ST-elevation acute myocardial infarction (AMI). However, timing of ischemia may be difficult to access by patient history (historical timing) alone. We hypothesized that an electrocardiographic acuteness score is better than historical timing for predicting myocardial salvage and prognosis in patients with anterior AMI treated with fibrinolysis or primary percutaneous coronary intervention. METHODS: One hundred seventy-five patients with anterior infarct without electrocardiogram (ECG) confounding factors were included. The ECG method for estimating timing of AMI was calculated using core laboratory measurements from the initial 12-lead ECG. Historical timing was recorded as time from symptom onset to initiation of reperfusion therapy. Myocardial salvage was determined by ECG, using the Aldrich score to determine the initially predicted myocardial infarct size and the Selvester score to determine the final QRS-estimated myocardial infarct size. RESULTS: The mean amount of myocardium salvage depended on ECG timing (43% [+/-38%] for "early" vs 1% [+/-56%] for "late"; P < .001), whereas myocardial salvage was independent of historical timing (P = .9). One-year mortality was predicted from ECG timing (P = .04). CONCLUSIONS: The ECG method of timing was superior to historical timing in predicting myocardial salvage and prognosis after reperfusion therapy. This study suggests that ECG estimated duration of ischemia might provide a better and objective means to select acute reperfusion therapy rather than the subjective patient history, which could preclude proper reperfusion in some patients with salvageable myocardium.

High-pressure balloon fracturing of small dysfunctional Mitroflow bioprostheses facilitates transcatheter aortic valve-in-valve implantation.

AIMS: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV). METHODS AND RESULTS: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days). CONCLUSIONS: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.

Simple risk stratification at admission to identify patients with reduced mortality from primary angioplasty.

BACKGROUND: Randomized trials comparing fibrinolysis with primary angioplasty for acute ST-elevation myocardial infarction have demonstrated a beneficial effect of primary angioplasty on the combined end point of death, reinfarction, and disabling stroke but not on all-cause death. Identifying a patient group with reduced mortality from an invasive strategy would be important for early triage. The Thrombolysis in Myocardial Infarction (TIMI) risk score is a simple validated integer score that makes it possible to identify high-risk patients on admission to hospital. We hypothesized that a high-risk group might have a reduced mortality with an invasive strategy. METHODS AND RESULTS: We classified 1527 patients from the Danish Multicenter Randomized Study on Fibrinolytic Therapy Versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI-2) trial with information for all variables necessary for calculating the TIMI risk score as low risk (TIMI risk score, 0 to 4) or high risk (TIMI risk score > or =5) and investigated the effect of primary angioplasty versus fibrinolysis on mortality and morbidity in the 2 groups. Follow-up was 3 years. We classified 1134 patients as low risk and 393 as high risk. There was a significant interaction between risk status and effect of primary angioplasty (P=0.008). In the low-risk group, there was no difference in mortality (primary angioplasty, 8.0%; fibrinolysis, 5.6%; P=0.11); in the high-risk group, there was a significant reduction in mortality with primary angioplasty (25.3% versus 36.2%; P=0.02). CONCLUSIONS: Risk stratification at admission based on the TIMI risk score identifies a group of high-risk patients who have a significantly reduced mortality with an invasive strategy of primary angioplasty.

Usefulness of quantitative baseline ST-segment elevation for predicting outcomes after primary coronary angioplasty or fibrinolysis (results from the DANAMI-2 trial).

The DANAMI-2 trial showed a 40% decrease in the composite end point with primary coronary angioplasty versus fibrinolysis. This result was primarily driven by a decrease in reinfarction, with no significant difference in mortality or stroke rates. The objective of this study was to determine the prognostic value of the sum ST-segment elevation (SigmaST) on baseline electrocardiography in patients who were randomized to receive primary coronary angioplasty versus fibrinolysis. In the DANAMI-2, 1,450 patients had baseline ST-segment deviation measurements and were assigned to quartiles according to SigmaST: 0 to 6.5, 7.0 to 9.5, 10.0 to 14.5, and 15.0 to 70.5 mm. The composite and component end-point rates at 30 days were determined for each quartile and chi-square for trend statistic was used to compare end-point rates across quartiles of SigmaST. The composite end point occurred more often with increasing SigmaST (p = 0.05). With regard to component end points, only mortality increased significantly with SigmaST (p = 0.03), whereas reinfarction and stroke rates did not. By multivariate analysis, only SigmaST and age were independent predictors of mortality. The relative benefit of primary coronary angioplasty was similar for all SigmaST quartiles. In conclusion, the magnitude of SigmaST correlates with increased mortality at 30 days, thus driving the composite end point rate. Regardless of SigmaST, patients had a lower composite end-point rate with primary coronary angioplasty than with fibrinolysis.

Transcatheter aortic valve implantation in a young heart transplant recipient crossing the traditional boundaries.

Transcatheter aortic valve implantation (TAVI) is an established therapeutic alternative to surgical aortic valve replacement (SAVR) in high-risk or inoperable patients with symptomatic aortic valve stenosis. Hitherto, TAVI is not recommended in young and low-intermediate risk patients. However, TAVI may also serve as an alternative to SAVR in selected young patients, e.g., patients who have previously undergone multiple cardiac surgery procedures. We report a case of trans-femoral TAVI in a 25-year-old heart transplant (HTx) recipient with prior surgery for congenital heart disease.

Prosthetic valve endocarditis after transcatheter aortic valve implantation-diagnostic and surgical considerations.

Prosthetic valve endocarditis (PVE) after transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR) is a potential life threatening complication. Better understanding of the incidence, predictors, clinical presentation, diagnostic measures, complications and management of PVE may help improve TAVI long-term outcome. We report a case of TAVI-PVE in an 80-year-old high risk patient in whom SAVR was successfully performed. We have reviewed literature regarding TAVI-PVE.

Danish multicenter randomized study on fibrinolytic therapy versus acute coronary angioplasty in acute myocardial infarction: rationale and design of the DANish trial in Acute Myocardial Infarction-2 (DANAMI-2).

BACKGROUND: Randomized trials have indicated that primary coronary angioplasty performed in patients admitted directly to highly-experienced angioplasty centers offers certain advantages over intravenous fibrinolytic therapy. However, the large majority of patients with acute myocardial infarction are submitted to hospitals without a catheterization laboratory. This means that additional transportation will be necessary for many patients if a strategy of acute coronary angioplasty is to be introduced as routine treatment. The delay of treatment caused by transportation might negate (part of) the benefits of primary angioplasty compared to fibrinolytic therapy given immediately at the local hospital. STUDY DESIGN: The DANish trial in Acute Myocardial Infarction-2 (DANAMI-2) is the first large-scale study to clarify, in a whole community, which of the 2 treatment strategies is best. A total of 1900 patients with ST-elevation myocardial infarction are to be randomized: 800 patients will be admitted to invasive hospitals and 1100 patients will be admitted to referral hospitals. Half of the 1100 patients admitted to referral hospitals will immediately be transferred to an invasive center to be treated with primary angioplasty. IMPLICATIONS: If acute transfer from a local hospital to an angioplasty center is the superior strategy, primary angioplasty should be offered to all patients as routine treatment on a community basis.

Syncope in paced patients with sick sinus syndrome from the DANPACE trial: incidence, predictors and prognostic implication.

OBJECTIVES: Syncope is a cause of significant morbidity in sick sinus syndrome (SSS) which may not be resolved with permanent pacemaker therapy. We aimed to determine the incidence, predictors and prognostic implication of syncope in paced patients with SSS. METHODS: We studied 1415 patients (mean age 72.9 years, SD 11.1) with SSS who were randomised in the DANPACE study to either rate-responsive single chamber pacing (n=707) or rate-responsive dual chamber pacing (n=708). Main outcome measures were patient-reported syncope after pacemaker implantation and mortality. RESULTS: Mean follow-up was 5.4 years (SD 2.6). A total of 247 (17.5%) patients experienced syncope after pacemaker implantation (135 (19%) from the rate-responsive single chamber pacing group, and 112 (15.8%) from the rate-responsive dual chamber pacing group. Predictors of syncope post pacemaker implantation included: age 0-39 years (HR 2.9, 95% CI 1.4 to 6.3, p=0.01; reference range 60-79 years), age ≥80 years (HR 1.4, 95% CI 1.0 to 1.8, p=0.03), syncope prior to pacemaker implant (HR 1.8, 95% CI 1.4 to 2.3, p<0.001), previous myocardial infarction (HR 1.5, 95% CI 1.1 to 2.1, p=0.03), heart failure (HR 1.4, 95% CI 1.0 to 1.9, p=0.046), and high Charlson comorbidity index (HR 1.6, 95% CI 1.1 to 2.2, p=0.01). Patients who experienced syncope post pacemaker implant had higher mortality compared with patients who did not (adjusted HR 1.6, 95% CI 1.3 to 2.1, p<0.001). CONCLUSIONS: Syncope in paced patients with SSS is common, and is associated with higher mortality. The predictors identified in this study suggest a multifactorial aetiology of syncope.

Aortic regurgitation after transcatheter aortic valve implantation of the Edwards SAPIEN ™ valve.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is established as an attractive treatment option for high-risk patients with aortic valve stenosis. One concern is the high risk of prosthetic valve regurgitation. This study aimed to examine for potential preoperative risk factors for postprocedural transcatheter heart valve regurgitation and to quantify the risk, degree, and consequences of postprocedural regurgitation. MATERIALS AND METHODS: 100 consecutive patients who underwent femoral (n = 22) or transapical (n = 78) TAVI were retrospectively reviewed. Echocardiographic valve regurgitation and clinical parameters were analyzed over the first year after TAVI. RESULTS: Seventy-five percent of all patients had prosthetic valve regurgitation. It was, however, only mild or absent in 64% of patients and did not require re-intervention in any of the patients in the series. The severity of the regurgitation appeared unchanged over the one-year follow-up period. Moderate to severe regurgitation was associated with significant yet stable dilatation of the left ventricle over one year and lesser NYHA class improvement three months after TAVI. Asymmetrical native valve calcification increased the risk of paravalvular regurgitation non-significantly. CONCLUSION: Transcatheter heart valve regurgitation seems to be mild in the majority of cases and unchanged over a 12 months follow-up period. While affecting left ventricular dimensions in moderate or severe cases, we observed no obvious undesirable consequences of the prosthetic valve regurgitation within the first year.

CHADS2 and CHA2DS2-VASc score to assess risk of stroke and death in patients paced for sick sinus syndrome.

OBJECTIVE: The risk of stroke in patients with atrial fibrillation (AF) can be assessed by use of the CHADS2 and the CHA2DS2-VASc score system. We hypothesised that these risk scores and their individual components could also be applied to patients paced for sick sinus syndrome (SSS) to evaluate risk of stroke and death. DESIGN: Prospective cohort study. SETTINGS: All Danish pacemaker centres and selected centres in the UK and Canada. PATIENTS: Risk factors were recorded prior to pacemaker implantation in 1415 patients with SSS participating in the Danish Multicenter Randomized Trial on Single Lead Atrial Pacing versus Dual Chamber Pacing in Sick Sinus Syndrome (Danpace) trial. Development of stroke was assessed at follow-up visits and by evaluation of patient charts. Mortality was assessed from the civil registration system. INTERVENTIONS: Patients were randomised to AAIR (N = 707) or DDDR pacing (N = 708). MAIN OUTCOME MEASURES: Stroke and death during follow-up. RESULTS: Mean follow-up was 4.3 ± 2.5 years. In the AAIR group 6.9% patients developed stroke versus 6.1% in the DDDR group (NS). There was a significant association between CHADS2 score and the development of stroke (HR 1.41; 95% CI 1.22 to 1.64, p < 0.001). CHA2DS2-VASc score was also significantly associated with stroke (HR 1.25; CI 1.12 to 1.40, p < 0.001). CHADS2 score (HR 1.46; CI 1.36 to 1.56, p < 0.001) and CHA2DS2-VASc score (HR 1.39; CI 1.31 to 1.46, p < 0.001) were associated with mortality. Results were still significant after adjusting for AF and anticoagulation therapy. CONCLUSIONS: CHADS2 and CHA2DS2-VASc score are associated with increased risk of stroke and death in patients paced for SSS irrespective of the presence of AF.